Clinical Research Associate: A Full Guide on Becoming A CRA
Clinical Research Associate
A Complete Guide on How to Become a Clinical Research Associate
Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.
As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.
This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).
For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.
Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.
Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).
Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.
CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T
his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.
Clinical Research Associate Certification Qualifications
Foreign Doctors Welcome: A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course.
Distinct Skillset: Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course.
Most Extensive Online Course: Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.
Superior Coursework: Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.
Diverse Career Opportunities: This high-demand science-based medical field offers diverse opportunities:
Work in the Private Sector: Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification.
Academic Opportunities: Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification.
Unmatched Flexibility and Knowledge: In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.
Why Take A CRA Certification Course
The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.
This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.
If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.
Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.
These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.
They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.
Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.
During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.
The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.
Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.
In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.
Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.
Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement
The Best CRA Certification Course For Entry-Levels
There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.
Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.
Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.
CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.
After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.
Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.
This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.
While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.
Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.
This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.
How To Get Experience For Clinical Research Associate Jobs
CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.
Clinical Research Job Advising: Kunal at ClinicalTrialPodcast
Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.
Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.
Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.
Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs
Always use a cover letter specific for the company and job when applying if you are not using a recruiter.
The ICH-GCP in Clinical Research
Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:
The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).
Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.
One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research.
Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.
The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.
In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.
Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:
The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).
Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.
One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research.
Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.
The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.
In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z
Qualifications and Qualities of a CRA
According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10.
The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.
In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.
Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.
Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hinges upon his/her ability to elicit the best from team members, in terms of both performance and probity.
Core Competency Framework for CRAs
To illustrate, the ACRP’s ‘Core Competency
Framework for Clinical Study Monitoring’
requires that a CRA should be able to identify
and correct compliance violations at a study
site. The CRA must not only bring such
violations to the attention of site staff, s/he
must induce them to take corrective action,
as well as reporting the matter and even
escalating it, where necessary14.
The table below summarizes the ideal
competencies of a CRA, and provides
insights on how each ability contributes to
the CRA’s performance.
CRA Career Path
In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.
However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field.
For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.
Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.
A Toe in the Door: CRA Certification for a Non-CRA
By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or as a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”
The simple answer is, yes, you can.
You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.
Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.
Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.
With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.
So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?
As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.
Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.
To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.
Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.
*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (American Nurses Credentialing Center), as well as Transcelerate Biopharma.
Training to be a CRA through CCRPS ACRAC
The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.
Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.
Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).
The program places particular emphasis on ethical practices in research with vulnerable populations.
Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).
They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.
Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.
A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).
Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.
A vital component of the training program involves empowering students to tackle challenging situations.
For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.
In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.
These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.
Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.
Clinical Research Associate Certification
Advanced Clinical Research Associate Certification (ACRAC)
Chapter 1: Introduction
This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on.
Chapter 2: Roles and Relationships in Clinical Trials
The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).
Chapter 3: Sponsor and Investigator Roles
In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.
Chapter 4: Clinical Trial Design
In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.
Chapter 5: ICH-GCP – Overview
The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.
Chapter 6: Ethical Research in Vulnerable Populations
The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.
Chapter 7: Adverse Events
Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.
Chapter 8: Clinical Trial Protocol
The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling.
Chapter 9: Protocol Deviations and Violations
Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts.
Chapter 10: IRB and DSMB
This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.
Chapter 11: Review Questions
The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.
Chapter 12: Site Monitoring Visits
In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.
Chapter 13: Site Qualification Visit (SQV)
The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.
Chapter 14: Site Initiation Visit (SIV)
The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel.
Chapter 15: Routine Monitoring Visit (RMV)
In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.
Chapter 16: Site Close-Out Visit (SCOV)
The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.
Chapter 17: Tools for Monitoring Visits
This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.
Chapter 18: Audit and Inspections
The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.
Chapter 19: Review Questions
The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.
Chapter 20: SDV and Informed Consent
In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).
Chapter 21: Case Report Form
The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).
Chapter 22: Quality Control and Safety
Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.
Chapter 23: Technology in Trials
In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined. The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies.
Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)
This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.
Chapter 25: Pharmacovigilance and Regulatory Affairs
Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.
Chapter 26: Investigational Product
In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.
Chapter 27: Local and Central Labs
The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.
Chapter 28: Review Questions
The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.
Chapter 29: Regulatory Documents in Clinical Trials
The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.
Chapter 30: CFR Title 21 Part 11 – Electronic Signatures
This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.
Chapter 31: New Drug Application
Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.
Chapter 32: Trial Master File
The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.
Chapter 33: Disclosures and Payments for PI, Site, Patients
In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.
Chapter 34: Patient Recruitment, Retention and Compliance
The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.
Chapter 35: Misconduct and Fraud
This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process.
Chapter 36: Review Questions
The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.
Chapter 37: Site Visit Templates
This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:
Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter
Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV
Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter
Site Close-Out Visit (SCOV) – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter
CRA transition letter – document notifying site PI of appointment of new monitor (yourself as CRA)
Chapter 38: Interviewing and Career
In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.
Chapter 39: Final Examination
This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position.
References
https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/
https://www.niaid.nih.gov/research/dmid-investigational-product
Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860
https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/
St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4
https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra
https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/
https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/
Clinical Research Associate Salary - What's the pay for a clinic research associate?
Here's What You Need to Know to Get a Clinical Research Associate Job
What's the pay for a Clinical Research Associate?: $61-$110K
What's the pay for a Clinical Research Associate?: $61-$110K
A Clinical Research Associate (or Monitor) is hired either in-house (“the trial site”) or externally (by the sponsor or CRO) to review clinical trial data and ensure that investigational therapies are tested ethically and scientifically through performing site visits that review files like patient medical notes in order to ensure quality of trial data. The catch 22 of clinical research associate jobs is that the ICH GCP guidelines require both education AND experience in order to work in this role, so getting your foot in the door is tough. Once you get experience, your education (i.e., certifications or degrees showing understanding of additional responsibilities) can help promotes you quickly through the CRA career ladder. For those looking to understand more about these guidelines, the ICH-GCP course might be a crucial step.
How to become or get promoted as a clinical research associate?
Having a certification through CCRPS’s accredited Advanced Clinical Research Associate Certification (CRA) course can help professionals 1) get promoted 2) get a raise 3) improve efficiency 4) get hired as a Clinical Research Associate. Additionally, those interested in broader roles in clinical research may consider the Clinical Research Coordinator course, the Pharmacovigilance Certification, or the Clinical Trials Assistant Training.
How much does a Clinical Research Associate make in the United States?
The average Clinical Research Associate salary in the United States is $61-110K. Salary ranges can vary widely depending on many important factors, including education, certifications, additional skills, and the number of years you have spent in your profession. For those looking at a leadership role, the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification could be relevant. Furthermore, the Medical Monitor Certification can enhance skills for those specifically interested in medical monitoring aspects.
Clinical Research Associate (CRA) Salary
Per Payscale “An entry-level Clinical Research Associate (CRA) with less than 1 year experience can expect to earn an average total compensation (includes tips, bonus, and overtime pay) of $55,588 based on 203 salaries. An early career Clinical Research Associate (CRA) with 1-4 years of experience earns an average total compensation of $66,245 based on 1,118 salaries. A mid-career Clinical Research Associate (CRA) with 5-9 years of experience earns an average total compensation of $76,086 based on 294 salaries. An experienced Clinical Research Associate (CRA) with 10-19 years of experience earns an average total compensation of $81,540 based on 157 salaries. In their late career (20 years and higher), employees earn an average total compensation of $83,342.”
Determine CRA Salary by location using Payscale
CRA Career Progression - Indeed
Salary: Clinical Research Associate
Research Associate Salary resource: Click here to see the CRA Salary Range from 1,800+ employers
Clinical Research Associates Pay: Clinical Research Associate Salary in United States (by city)
Durham, NC - $97K
New York, NY, Irvine, CA, Houston, TX - $95K
Philadelphia, PA - $92K
Atlanta, GA - $84K
Raleigh, NC - $82K
Chicago, IL - $79K
Payscale: CRA Career Pathway
Senior Clinical Research Associate Salary
The average salary of a Senior Senior Clinical Research Associate is ~105K per year ($54/hour, $2k/week, $9k/month). This can range from $81k to $139k.
Glassdoor Salary range for Senior CRAs
Starting Salary of a Clinical Research Associate Position is between $60,000 and $65,000
Some employers may prefer hiring entry-level clinical research associates with less experience in clinical research so they can learn their job functions by training under Senior CRAs or CRA IIs.
Clinical Research Associate II Salary is $86,677 / yr
CRA II @ PPD: $84,733/yr
CRA II @ PRA Health Sciences: $96,017/yr
CRA II @ IQVIA: $79,412/yr
CRA II @ ICON: $100,000/yr
Comment below how much you get paid and what helped you get promoted!
Having a certification through CCRPS’s accredited Advanced Clinical Research Associate Certification course can help professionals 1) get promoted 2) get a raise 3) improve efficiency 4) get hired as a Clinical Research Associate.
What Is a Clinical Research Associate?
Clinical Research Associates are those responsible for the planning, setting up, and coordinating of clinical trials. They provide technical assistance for experiments, make sure that the scientists that are involved in the clinical research trials comply with regulatory standards, and also collect results during the clinical trials. When the trials are over they are also to be involved in the presentation of the results to the public in a manner that is useful and understandable.
Clinical research associates are those responsible for the planning, setting up, and coordinating of clinical trials. They provide technical assistance for experiments, make sure that the scientists involved in the clinical research trials comply with regulatory standards such as ICH-GCP, and also collect results during the clinical trials. When the trials are over, they are also involved in the public results presentation.
The amazing part about being a clinical research associate is that jobs are available for them in both the laboratory and office settings.
SPECIALIZATIONS
They focus on the following:
Designing and implementing clinical research trials
Training staff, which could be enhanced by taking the Clinical Trials Assistant Training course.
Monitoring progress
Screening test subjects
Presenting findings
Helping maintain the database of all clinical research trainees
SKILLS
As a clinical research associate, you should have the following skills:
Communication skills
Science knowledge
Strong mathematics knowledge base
These core skills are what you need in the clinical research profession.
EDUCATIONAL REQUIREMENTS
As a clinical research associate, you should have one of the following:
High school diploma and 6,000 hours of experience.
An associate degree in clinical research fields and 4,500 hours of experience.
A Bachelor's, Master's, or Registered Nurse degree and 3,000 hours of clinical research experience.
You can come from a variety of medical sciences or health-related fields, or from a nursing background as an RN. Courses offered in hospital and clinical related ethics, team management, and research methodologies will be valuable to your education. Consider advancing your career with certifications like the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.
SALARY
The median salary of a clinical research associate boasts of $90,310 annually and it is always on the rise. Plus, there is always a ready market for clinical research professionals.
Explore more about this field with specific courses like the Clinical Research Coordinator training, Pharmacovigilance Certification, or the CRA course. These certifications will equip you with the necessary skills and knowledge to excel in this growing industry.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
What is the Best CRA Training Program for You?
To any CRA, proper training and certification is critical. After all, employers want to hire applicants that are proficient and knowledgeable. At CCRPS, we can help jump start your career with our flexible, ACCRE accredited program. In addition, check out some of our other CRA articles below to learn more about the field and position.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Enhance Your Skills with Specialized Training:
If you're looking to specialize in specific areas within clinical research or further develop your expertise, consider enrolling in our comprehensive courses:
Clinical Research Coordinator: Dive deep into the responsibilities and intricacies of coordinating clinical trials. Enroll here.
Pharmacovigilance Certification: Master the principles and practices of drug safety monitoring. Enroll here.
CRA (Clinical Research Associate): Hone your skills as a CRA and excel in managing clinical trial conduct. Enroll here.
ICH-GCP (International Conference on Harmonisation - Good Clinical Practice): Understand the global standards for conducting clinical trials. Enroll here.
Clinical Trials Assistant Training: Learn the essentials of supporting clinical trial operations effectively. Enroll here.
Advanced Clinical Research Project Manager Certification: Elevate your career with advanced project management skills tailored to clinical research. Enroll here.
Advanced Principal Investigator Physician Certification: Equip yourself with the expertise needed to lead clinical trials as a principal investigator. Enroll here.
Medical Monitor Certification: Gain the necessary skills to oversee clinical trial safety and medical aspects effectively. Enroll here.
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Clinical Research Associate Job Description
Read more about the Clinical Research Associate Jobs descriptions and skills that require in Clinical Research Associate post. Visit us now!
Clinical research associates (CRAs) are responsible for organizing and administering clinical research trials for new or current drugs so that they may assess the risks and benefits of using them. The major responsibilities of clinical research associate jobs are:
They write out the procedures for administering drug trials.
They identify and brief appropriate trial investigators.
They make use of their knowledge of the basics of clinical research to collect and analyze and record data.
They design trail materials and supply the research study centers with the quantities that they need.
They monitor the process of the trial from the start to the finish.
Clinical research associates are always present in the institute of clinical research because of the essential duties that they perform. However, the position is very competitive according to various job websites. As competitive as it is, it is also lucrative. Clinical research associate can work in government clinical research institute, pharmaceutical companies, private owned clinical research institute, etc. Their salaries may differ based on how much the individual companies or employees offer at their different choice of work place. But on the average, clinical research associates are paid around $65,000 per year. This leaves the pay at about $24 - $25 per hour.
There are various factors that can affect how much a clinical research associate (CRA) goes home with at the end of the month or cumulatively at the end of the year. These factors can be the location of the company, that is, the economic strength of the country or city where they are working, the degree or certificate or the level of education and exposure that the CRA has, the number of years if working experience that they have accumulated. These factors work together to determine how much they take home.
You can boost your chances of getting a higher pay, in the region of $85,000 to $90,000 or even more by getting the necessary education and certification. For example, experienced contract CRAs can earn up to $300k.
Skills required to be successful as a clinical research associates include:
A logical and inquisitive mindset with quick thinking.
Good organizational abilities.
Excellent communication skills. Both written and verbal are important.
Commercial awareness.
Confidence
The basic requirement to be a clinical research associate is an undergraduate degree or a postgraduate degree in related life sciences fields (like biology, toxicology, microbiology, pharmacology, biochemistry), nursing, or medical sciences (like immunology, pharmacy, anatomy, physiology, or medicine). Due to the competitive nature of the job, some people go ahead and obtain a doctorate degree in any of the above mentioned fields. This gives them a better chance of getting a senior level job and increase their promotion prospect.
Beyond academic degrees, you need to be certified to become a clinical research associate. You need certification from organizations like ACRP (association of clinical research professionals) or SOCRA (society of clinical research associates). You will need to obtain certification course and pass the exams to become certified. At ccrps.org, we offer ACCRE accredited courses and insider information on everything you need to know for a career in clinical research. You can click here to see the offers for the courses available.
Take courses from CCRPS and learn more on how to become a clinical research professional:
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How to Become a CRA and Succeed
The Clinical Research Associate (CRA) is one of the most popular entry-level job in the clinical research sector. It is also one of the most competitive and lucrative positions for new hires. How do you stand out from hundreds of other applicants? You need to build field intelligence and experience.
Knowledge is power in the clinical research industry. For example, did you know that there are loads of differences between the clinical trial and clinical research? If you pay attention to learning the critical details of the field, employers will see and appreciate the effort you put into understanding the field.
There are many institutions that provide clinical research courses for aspiring professionals. However, CCRPS' reputation for the best-in-class programs is offered at the competitive prices is unbeatable. Our world-class facilities is known for teaching both basic and advanced lessons that help professionals in clinical research.
Improve your Clinical research job qualifications
To become a CRA, you’ll need an undergraduate degree in medical science, life science, biotech or nursing and a certification. Alternatively, you can use your diploma from a clinical research program from a reputable institution. If you have a graduate degree in the clinical research, then you are eligible for senior level positions and a higher pay grade.
In addition to your degree, individual should demonstrate their interest by joining a clinical research associate program from a trustworthy institution, such as our CRA certification. There are many specific skills required to become a qualified clinical research associate, and they aren’t always taught in every programs. You must understand the healthcare system, clinical research, healthcare regulation and procedures and other things for successfully regulating the growth of the healthcare products.
Presently, individuals who want to become a CRA should be capable of preparing a clinical development plan and ensuring the clinical trial data. They should have the overall understanding of the liabilities and responsibilities of performing the study with human subjects. They have to know all the challenges and restrictions of implementing and retaining databases.
At CCRPS, our program will walk you through what you need to know to become a CRA. Our AACRE accredited program is curated by real life professionals with years of direct experience in clinical research. Best of all, you can learn at your own pace. With our flexible online learning model, you can take your education anywhere you do. Enroll and start working toward your dream career through our online CRA certification program today. If you’d like to learn more, check out some of our other CRA articles below or explore additional programs like our ICH-GCP course, Clinical Research Coordinator course, and the Pharmacovigilance Certification.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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Clinical Research Associate Training and Placement
The role of the clinical research associate is very important in clinical trials to ensure that medical devices, new treatments and new drugs are approved for patients' use.
This field is taken as a certificate program course in many schools. You may also discover the availability of associate degree programs depending on the school. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.
If you opt for an online program, different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as with the lecturers. Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.
These certificate programs are generally designed for professionals that are already in the medical fields like medical assistants, nurses etc, and are interested in moving to the field of clinical research. They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.
Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials. During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.
The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective, the need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience of clinical trials. Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.
In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to. Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies.
Take courses from CCRPS and learn more on how to become a clinical research professional. Explore courses like Clinical Research Coordinator, Pharmacovigilance Certification, CRA, ICH-GCP, Advanced Clinical Research Project Manager Certification, and Advanced Principal Investigator Physician Certification.
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CRA Exam Questions
29.Allocable costA cost that can be assigned to a project or an activity based on the relative benefits received30.allowable only if approved by the sponsoring agencyAccording to OMB Circular A-21, costs incurred prior to the project start date are:31.All vertebrate animalsThe Federal Animal Welfare Act applies to which of the following animal species32.AnnuallyIf an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit?33.The Anti-Kickback Act of 1986Which of the following aims at deterring subcontractors from making payments and contractors from accepting payments for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract or a subcontract relating to a prime contract?34.An anti-lobbying certification is required on federal grants, cooperative agreements and contracts exceeding a MINIMUM of:
a. $100,000
b. $500,000
c. $1,000,000
d. 10,000,000a. $100,00035.approval of student's embassyIn order for a foreign national doctoral student researcher to work on a federal grant in an American institution, it is necessary for the student to have36.Assure that the highest quality proposals are selected for funding in an equitable mannerWhich of the following is the primary purpose of federal proposal review processes?37.An award similar to a grant, and anticipates having substantial involvement in research activities once the award has been made.What is cooperative agreement?38.Award terms and conditionsA Notice of Award typically includes which of the following
39.Basic and containment procedures designed to protect personnel and the environmentWhich of the following best describes essential laboratory biosafety levels in medical research?40.Bayh-Dole ActWhich of the following was enacted as a uniform patent policy among the many federal agencies that fund research?41.BequestsA type of donation or gift with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs.42.Break refreshments at a project sponsored workshopUsing the criteria contained in 2 CFR 220, OMB Circular A-21, which of the following costs would most likely be allowable as a direct expenditure item on a federal grant?43.Budget period is yearly. Project period is the life of the contract.What's the difference between budget period and project period?44.a cabinet-level departmentThe Office for Human Research Protection is administered by45.A career development programAn employee in a position which does not enable realization of full potential would benefit most from46.cash flow statementAn important tool you may use to measure and track the flow of
cash into and out of your operation47.Certifications and representationsJust-In-Time initiatives postpone the submission of which of the following items until a decision to make an award is reached?48.Change in allocation within a single budget categoryWhich of the following changes does not require prior National Science Foundation approval?49.Change OrderA written order signed by the contracting officer, directing the contractor to make changes that the changes clause of the contract authorizes the contracting officer to order without the consent of the contractor.50.Chief Executive Officer or Vice President of ResearchWho appoints the chair for each committees at universities
$40,000If an agency requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from agency, what is the additional amount that the institution must cost share?2.$50,000An investigator on a NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the Institution's facilities and administrative cost (indirect cost) rate (based on MTDC) is 50% how much money will be available for the equipment3.$100,000An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of4.$165,000An institution has an indirect cost rate of 40%. A research project is budgeted at $125,000 in direct costs including an item of equipment at $25,000 which is the only item excluded from the indirect cost base. What is the total cost for the project?5.1.Publicly known information.2. Already known information.3. Information received from others. 4. Information shared with others. 5. Independently developed information. 6. Information not included in the nondisclosure agreement.What is not included in a Nondisclosure Agreement?6.1) Resubmit 2)Appeal 3)Advice to look for other opportunitiesWhat happens to a proposal if it isn't funded?7.2NIH limits how many resubmissions on proposals?8.2 CFR 215 OMB A-110Administration Regulation for Education Institutes, Hospitals, and Non profits9.2 CFR 220, OMB Circular A-21Deals with cost determination but does not identify the circumstance or dictate the participation in the financing of a project
10.2 CFR 225 OMB A-87Cost Principles for State, Local, and Indian Tribal11.2 CRF 215 (OMB Circular A-110) provides regulations governing which of the following for educational institutions?
a. Administrative requirements for contracts
b. Administrative requirements for grants and cooperate agreements
c. Cost principles for grants and cooperative agreements only
d. Administrative requirements and cost principles for grants and cooperative agreementsb. Administrative requirements for grants and cooperate agreements12.3 years from submission of final report of expendituresRecipients of federal grant funds must retain records for a MINIMUM of13.5 membersAn IRB is required to have at least:14.6-9 monthsThe National Science Foundation indicates decisions on the funding of grant proposals should normally take15.26%The administrative cap on federal negotiated F&A rates is equal to16.90Under Expanded Authority, pre-award costs up to _____ days prior to the effective date of the award the PI can accrue charges before the award start date.17.90 daysIf final financial reporting (FS 425 Report) to federal agencies is not completed with in the typical ___ days, the institution is out of compliance18.90 daysWhen granted expanded authorities, pre-award costs on a federal grant may be incurred by an institution within a MAXIMUM of how many days prior to the official start date?19.90 daysHow many days do recipients of federal grants funds have to submits final reports after completion of the project?
20.A-102State and local governments are subject to which of the following OMB Circulars?21.AbstractShould be 5,000 to 25,000 words in length. This summary should demonstrate to the reader the most important parts of each of the sections of the research proposal in around 200 words.22.Accept, Decline or NegotiateWhen an award is made an institution has the following options.23.Access to federally funded research data is required under the:
a. Solomon Act
b. Davis-Bacon Act
c. Shelby Amendment
d. Stevens Amendmentc. Shelby Amendment24.According to federal regulations, which of the following must be included in an Institution Review Board?
a. Ethicist
b. Attorney
c. Member of the clergy
d. Member unaffiliated with the institutiond. Member unaffiliated with the institution25.Acquisition of property or servicesA procurement contract is used for the purpose of26.Administrative requirements for grants and cooperative agreements only2 CFR 215, OMB Circular A-110 provides regulations governing which of the following for educational institutions?27.AdobeWhat is required to use Grants.gov28.advise student to apply to the federal agency to request a proposal 90 days after proposal was submittedIf a graduate student comes into a university sponsored research office claiming that because of the federal Freedom of Information Act (FOIA) he has the right to obtain a copy of a recently submitted proposal, the research administrator should
29.Allocable costA cost that can be assigned to a project or an activity based on the relative benefits received30.allowable only if approved by the sponsoring agencyAccording to OMB Circular A-21, costs incurred prior to the project start date are:31.All vertebrate animalsThe Federal Animal Welfare Act applies to which of the following animal species32.AnnuallyIf an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit?33.The Anti-Kickback Act of 1986Which of the following aims at deterring subcontractors from making payments and contractors from accepting payments for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract or a subcontract relating to a prime contract?34.An anti-lobbying certification is required on federal grants, cooperative agreements and contracts exceeding a MINIMUM of:
a. $100,000
b. $500,000
c. $1,000,000
d. 10,000,000a. $100,00035.approval of student's embassyIn order for a foreign national doctoral student researcher to work on a federal grant in an American institution, it is necessary for the student to have36.Assure that the highest quality proposals are selected for funding in an equitable mannerWhich of the following is the primary purpose of federal proposal review processes?37.An award similar to a grant, and anticipates having substantial involvement in research activities once the award has been made.What is cooperative agreement?38.Award terms and conditionsA Notice of Award typically includes which of the following
39.Basic and containment procedures designed to protect personnel and the environmentWhich of the following best describes essential laboratory biosafety levels in medical research?40.Bayh-Dole ActWhich of the following was enacted as a uniform patent policy among the many federal agencies that fund research?41.BequestsA type of donation or gift with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs.42.Break refreshments at a project sponsored workshopUsing the criteria contained in 2 CFR 220, OMB Circular A-21, which of the following costs would most likely be allowable as a direct expenditure item on a federal grant?43.Budget period is yearly. Project period is the life of the contract.What's the difference between budget period and project period?44.a cabinet-level departmentThe Office for Human Research Protection is administered by45.A career development programAn employee in a position which does not enable realization of full potential would benefit most from46.cash flow statementAn important tool you may use to measure and track the flow of
cash into and out of your operation47.Certifications and representationsJust-In-Time initiatives postpone the submission of which of the following items until a decision to make an award is reached?48.Change in allocation within a single budget categoryWhich of the following changes does not require prior National Science Foundation approval?49.Change OrderA written order signed by the contracting officer, directing the contractor to make changes that the changes clause of the contract authorizes the contracting officer to order without the consent of the contractor.50.Chief Executive Officer or Vice President of ResearchWho appoints the chair for each committees at universities
51.A citation of the contract clause authorizing the terminationWhich of the following information must be included in the notification by a federal officer to the contractor to terminate a contract for convenience52.Clinical trial AgreementWhich of the Following types of documents is most appropriate for testing the efficacy and safety of a new drug, device, or vaccine?53.Code of Federal RegulationsThe following provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects54.cognizant agencyA Federal agency responsible for negotiating and approving facilities and administrative cost rate for an education institution on behalf of all other federal agencies is referred to as the55.Commons Business DailyWhich of the following sources is not commonly used for federal funding opportunities?56.Compliance approvalsRetention of which records are required by the OMB57.Contact legal, then contact program officer over concernsIf a PI received an award and his wife is using the lab and charging to the award. How would you handle it?58.The contractor fails to perform the services within the time specified or any extensionWhich of the following is a reason for a federal contracting officer to send a "Show Cause" notice to a contractor?59.Contract Work Hours and Safety Standards ActThis act would require that certain contracts contain a clause specifying that no laborer or mechanic doing any part of the work contemplated by the contract would be required or permitted to work more than a certain number of hours in any workweek60.control commodities and is governed by Department of CommerceIn Export Control, what does Export Administration Regulation control and who governs it61.control money: Governed by Department of Treasury.In Export Control, what does Office of Foreign Assets Control control and who governs it
62.Cooperative Research And Technology Enhancement Act hopes to enhance research among Universities, private and public sectors, by treating joint inventions as if they are a single owner but only if the collaborators sign an agreement prior to the invention being created.What is the CREATE Act?63.CopyrightIn which of the following areas of intellectual property is the concept of work-for-hire germane64.Cost Accounting StandardsIt is the ___________ that dictate the way in which a contractor must maintain its accounting system.65.Cost Accounting Standards (CAS) must be applied to awards:
a. without federal funding
b. received from any funding source
c. for federal contracts over $500,000
c. for all federal awards covered by 2 CFR 230 (OMB Circular A-122)c. for federal contracts over $500,00066.Cost of Living Allowance COLAgranted to employees based in a foreign city, where cost of living is higher than in Washington, D.C.67.Cost Principals for Educational InstitutesWho is the 2 CRF 220, OMB Circular A-21 for68.A cost reimbursement sub agreementRequires that the subrecipient use best efforts to complete the research
69.Cost sharing must be:
a. verifiable from records
b. included with other federal awards
c. paid from federal funds if it is a fellowship
d. donated third party contributionsa. verifiable from records70.cost sharing occurs when the sponsored program requires financial support for the project from the awarded institution as a condition of the award.What is involuntary committed (mandatory) cost sharing?71.Data Management Plan RequirementNo more than 2 pages and must describe how the proposal will conform to NSF policy on dissemination and sharing of research results.72.Data sharing plan/ Publish and ShareApplicant who are planning to share data may wish to describe briefly the expected scheduled for data sharing, the format of the final data set, the documentation to be provided, whether or not any analytic tools also will be provided and so on ...73.Debarment and suspension rulesWhich of the following is included in 2 CFR 215, OMB Circular A-110?74.Default and convenienceTwo critical termination clauses of the General Provisions of a federal contract75.Department of AgricultureWhich agencies is responsible for administering the Animal Welfare Act?76.Department of EnergyWhich of the following agencies does NOT fund health science research77.Director of Human ResourceWho should administer progressive discipline to an employee?78.the Director of the institution's animal careAs required an IACUC Committee must contain all but one of the following a. a Doctor or Veterinary Medicine, b. a practicing scientist experienced in research with animals, c. the Director of the institution's animal care facility, d. a person not affiliated with the institution79.Each calendar yearOMB Circular A-21, time and effort reporting must be submitted to the institution a MINIMUM of once
80.Each organization using animals in Public Health Service projects must provide written assurance of its compliance with:
a. regulations requiring full-time staff veterinarian
b. provisions for an organizational program for the care and use of animals
c. standard for accreditation with the American Association for Accreditation of Laboratory Animal Care
d. requirements for organizational training and instruction program in the human practices of animal care and used. requirements for organizational training and d. requirements for organizational training and instruction program in the human practices of animal care and use81.Efficient and effective operations and reliable financial reporting are the objectives of:
a. internal controls
b. research compliance
c. cost transfer processes
d. postaward administrationa. internal controls82.electronic funds transferThe federal government prefers to disburse funds under federal grants via83.enacted to assure that a fair portion of federal contracts are placed with small businesses.What is the Small Business Act?84.Equipment donated at fair market valueIs allowable as cost sharing85.Established fundamental national policy for the environment and established the council on environmental qualityWhat is the National Environmental Policy Act?86.Evaluation PlanIt is important to define carefully and exactly how success will be determined.
87.E-VerifyFAR 52.222-54, which requires that federal contractors or subcontractor verify the employment eligibility of all new hires on a contract through an electronic screening database.88.Every 3 yearsHow often do approved animal protocols need to be reviewed by the Institutional Animal Care and Use Committee (IACUC)89.Executive Branchbranch of the government is responsible for enforcing the laws of the land. The president, vice president, department heads (cabinet members), and heads of independent agencies carry out this mission.90.Executive Level II $181,500NIH Salary cap is at what percentage?91.Executive Level I, II, IIIWhat is the highest level of salary?92.Executive Orders 8248 and 11541Establishing the divisions of the Executive Office of the President and defining their functions and duties
Source and -Prescribing the duties of the Office of Management and Budget and the Domestic Council in the Executive Office of the President93.Expanded AuthoritiesDelegates to grantees authorization of one year, no cost extension94.Expanded Authority_____waives certain prior approval requirements by a federal sponsoring agency. It is used only for changes that are necessary for the completion of the project within its original scope and original total budget.95.FabricationMaking up data or results and recording or reporting them96.A facilities & administrative costs (indirect cots) rate is usually established based on:
a. prior actual costs
b. reimbursed costs
c. capital expenses
d. unaudited expensesa. prior actual costs
97.A facilities and administrative cost (indirect cost) may be a direct cost if:
a. it meets the definition of allocable
b. "unlike circumstances" are present
c. normally allowable on federal or federal flow-through awards
d. the award activities are like those generally charged as facilities and administrative costs (indirect costs)b. "unlike circumstances are present98.Faculty have share in the companyConflict of interest may exist when medical faculty members conduct drug clinical tests for a company if99.A faculty member has a 5-yar federal NIH grant which will terminate 8/31, with $14,000 remaining on 7/15 of the same year. A competing continuation was recommended for approval but not funded. Which of the following is the most appropriate advise for the research administrator to give to the member
a. buy as much equipment as possible before the grant year ends
b. request a second review of the continuation application for the NIH
c. transfer laboratory personnel salaries to the to use up the remaining funds
d. request a 1-year, no-cost extension of the grant while revised continuation is under preparationd. request a 1-year, no-cost extension of the grant while revised continuation is under preparation100.F&A is not allowed to be charged on the following?Participant support*, equipment, capital equipment, patient care, tuition, building renovations, rental costs for non-University owned space, scholarships/fellowships, Subawards in excess of $25,000.
*NSF only
101.FalsificationManipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record102.FARIn order for a contractor to be awarded a federal contract, he must comply with the provisions set forth by:103.FARThe overall guiding principle of __________ is to have an acquisition system that can satisfy customer's needs yet minimize administrative overhead without sacrificing integrity, fairness, openness and public policy objectives.104.A federal agency responsible for negotiating and approving facilities and administrative cost (indirect costs) rates for an educational on behalf of all other federal agencies in referred to as the:
a. lead agency
b. cognizant agency
c. sponsoring agency
d. governmental agencyb. cognizant agency105.Federal commonsWhat is an Internet grants management portal which serves the grantee organization community?106.Federal expanded authorities permit which of the following without additional sponsor approvals?
a. Rebudgeting
b. Change of the Institution
c. Renovation of laboratory space
d. Change of the principal investigatora. Rebudgeting107.Federal Financial Assistance Management Improvement Act 1999 Public Law 106-107The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has
108.The federal government prefers to disburse funds under federal grants via:
a. letters of credit
b. reimbursement check
c. electronic funds transfer
d. advanced treasury checksc. electronic funds transfer109.Federal regulations governing the use of humans in researchAlways require full informed consent of the subject or the subject's guardian110.The first $25,000When a subaward is involved in a federal grant to a large university, on what portion of the subawardee's budget does the prime institution recover facilities and administrative cost(indirect cost)?111.FOA instructions always supersede these form instructions.If you have a funding opportunity announcement (FOA), which instructions do you go by... the research form or the FOA112.For copyrighted works which result from federally sponsored activities the federal government usually requires
a. disclosure of the copyright only
b. one copy of the official archives
c. a royalty-bearing , exclusive, and irrevocable license
d. a royalty-free, nonexclusive, and irrevocable licenseb. one copy of the official archives113.Formulation of the President's Budget;
Action by the Congress; Presentation (to Congress) and-Execution of enacted budget lawsWhat are the 3 main phases in the Federal Budget Process114.Freedom of Information Act (FOI)What act brought this on FFATA?
115.From any institution that receives more than $700,000 in federal fundingUnder which of the following conditions is a Certificate of Current Cost and Pricing required116.The Fulbright Program provides opportunities for
a. teaching abroad
b. service abroad
c. teaching n low income communities
d. construction of low income housinga. teaching abroad117.Goals/Objectives/SOW/ImplementationApplicant should explain the expected results and benefits of each objectives.118.House of Representativesa provision or report language included primarily at the request of a Member, Delegate, Resident Commissioner, or Senator providing, authorizing or recommending a specific amount of discretionary budget authority, credit authority, or other spending authority for a contract, loan, loan guarantee, grant, loan authority, or other expenditure with or to an entity, or targeted to a specific State, locality or Congressional district, other than through a statutory or administrative formula driven or competitive award process.119.How does an institution find their DUNS numberYou can contact your office of sponsored research or you can also log in to the eRA Commons.
120.How many days do recipients of federal grant funds have to submit final reports after completion of the project period?
a. 30
b. 60
c. 90
d. 120c. 90121.How often do approved animal protocols need to be reviewed by the Institutional Animals Care and Use Committee (IACUC):
a. Annually
b. Semiannually
c. Every 2 years
d. Every 3 yearsd. Every 3 years122.How to do business internationallyThe Office of Commercial and Business Affairs (CBA) plays a major role in coordinating trade and investment matters to support U.S. firms doing business overseas. Our mission is to engage U.S. government resources to assist and promote U.S. business interests overseas, and to ensure that private sector business concerns are fully integrated into U.S. foreign and economic policy.123.iEdisonInteragency Extramural Invention Information Management System helps government grantees and contractors comply with a federal law, the Bayh-Dole Act regulations require that government funded inventions be reported to the federal agency who made the award
124.If a graduate student comes into a university sponsored research office charging that because of the federal Freedom on Information Act (FOIA) he has the right to obtain a copy of recently submitted proposal, the research administrator should
a. provide student with a complete copy of the proposal
b. provide student with a copy of the proposal with proprietary and salary information blacked out
c. advise student to apply to the federal agency to request a proposal 90 days after the proposal was submitted
d. tell the student to wait to apply to the federal agency until after the decision is made on the proposald. tell the student to wait to apply to the federal agency until after the decision is made on the proposal125.If an agency requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from the agency, what is the additional amount that the institution must cost share?
a. $40,000
b. $50,000
c. $100,000
d. $220,000$50,000
$200000 / .8 = $250,000
$250,000-$200,000 = $50,000126.If an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit?
a. Annually
b. Biennially
c. Triennially
d. At the discretion of its governing bodya. Annually127.If a principal investigator proposes to conduct research involving human subjects who will take a standardized educational test, but the test will not include any names or other identifying information, the proposal should be:
a. reviewed by the full Institutional Review Board
b. submitted for expedited review by the Institutional Review Board
c. submitted for review to the Office of Human Research Protection
d. treated under organization's policy as exempt from reviewb. submitted for expedited review by the Institutional Review Board
128.The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has been mandated by:
a. e-Government strategies
b. new audit policies at the Office of Management & Budget
c. Office of Science & Technology Policy
d. the Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107).d. the Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107).129.indemnityOne may use what kind of clause to require that one party indemnify the other when certain expenses are incurred130.individual account in an approved accounting systemUpon receipt of awarded projects, educational institutions are required to establish131.Information is made available to the public by publication in the Federal Register, upon request given a description of the records desired and provides an opportunity to read and copy records at convenient locations.What is the Freedom of Information Act?132.In order for a foreign national student researcher to work on a federal grant in an American institution, it is necessary for the student to have:
a. a visa
b. United States citizenship
c. evidence of English proficiency
d. approval of student's embassya. a visa133.The Institutional Animal Care and Use Committee (IACUC) is required to inspect animal facilities a MINIMUM
a. one a month
b. twice a year
c. once a year
d. once every three yearsb. twice a year134.Institutional Biosafety CommitteeWhich of the following is mandated for the oversight of research involving recombinant DNA
135.Institutional National Research Service AwardsThe National Institutes of Health requires a written description of a program for providing instruction in the responsible conduct of research for136.The Institutional Official for a sponsored research projectThe individual authorized by the Board of Trustees to sign on behalf of the institution137.Institutions, InvestigatorsWho is covered by the COI regulation138.Institutions that have more than $25,000,000 in federal grants or contractsWhich of the following would be required to file a disclosure statement (DS-2) with the federal government?139.internal controlsEfficient and effective operations and reliable financial reporting are the objectives of140.International Traffic in Arms Regulations (ITAR) are controlled by the :
a. United Nations
b. U.S. Department of State
c. U.S. Department of Homeland Security
d. Bureau of Alcohol, Tobacco, and Firearmsb. U.S. Department of State141.In the credentials boxWhere do you put the ERA Login?142.In the event of cost overrun by a subcontractor, who would be held responsible by the funding sources?
a. Subcontractor only
b. Prime contractor only
c. Project director and subcontractor
d. Project directly and prime contractora. Subcontractor only
143.An investigator on an NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the institution's facilities and administrative cost (indirect costs) rate (based on MTD) is 50%, how much money will be available for the equipment?
a. $25,000
b. $33,333
c. $50,000
d. $75,000d. $75,000
$50,000 X 1.50 = $75,000144.Involves a conflict of interestFaculty member is a major stockholder in a for profit company receiving a university contract145.Is a binding contract made between two parties, one of whom is the "Sponsor" or the company or individual sponsoring the clinical trial, while the other is the "Institution" or the organization or hospital receiving the sponsorship for conducting clinical trials.What is the Clinical Trial Agreement?146.Is intended to give credit where credit is due. Requires acknowledgement of Federal grant support when issuing statements, press releases, requests for proposals, bid solicitations, etc.What is the Stevens Amendment?147.is the grant of a property right to the inventor, issued by the Patent and Trademark Office. The term of a new patent is 20 years from the date on which the application was filedWhat is a patent?148.is to ensure that employers provide employees with an environment free from recognized hazards, such as exposure to toxic chemicals, excessive noise levels, mechanical dangers, heat or cold stress, or unsanitary conditions.What is the Occupational Safety & Health Act?149.Is usually riskier than a cost reimbursement contractWhich of the following best describes a fixed-price contract150.It is a public-private partnershipWhich of the following correctly describes FirstGov
151.It's required before an award at the proposal stage.If you don't have ERA Commons password, when is it required for an IRB?152.Judicial BranchCourts decide arguments about the meaning of laws and how they are applied. They also decide if laws violate the Constitution—this is known as judicial review, and it is how federal courts provide checks and balances on the legislative and executive branches.153."Just in time" initiatives postpone the submission of which of the following items until a decision to make an award is reached?
a. Full proposal
b. Budget justification
c. Certification and representations
d. Research background of principal investigatorc. certification and representations154.Land acquisitionIn a Construction Grant, which is allowable155.Law passed to protect certain species of marine mammals deemed as being in danger of extinctionWhat is the Marine Mammal Protection Act?156.Legislative BranchArticle I of the Constitution establishes the legislative or law making branch of government. It has a two-branch Congress—the Senate and the House of Representatives—and agencies that support Congress.157.Let SRO review the proposal then allow the PI to submitIf a federal agency requires a PI to submit online, what should be done158.Letter of supportA straight forward document stating that the institution is in support of the application to proceed and that it will host the proposed research should the application be successful.159.live, vertebrate animals onlyThe PHS policy governing the use and care of animals covers
160.Make sure budget/rates are accurate.If a PI submitted a proposal without going through the SRO office, what is our first concern?161.Mandates that a "Responsible Party" register and report results of certain "applicable clinical trials". Interventional studies of drugs, biologics, or devices that are subject to FDA regulations.What is the Food and Drug Administration Amendments Act (FDAAA)?162.Martial status of applicantUnder federal Equal Employment Opportunity provisions, a supervisor should NOT ask which of the following during an employment interview:163.Material Safety Data Sheet (MSDS) fileWhich of the following is essential to a Chemical Hygiene Plan?164.Material Transfer AgreementMTA165.Material transfer agreement (MTA)What is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes166.Material Transfer AgreementsRecommended so that disputes about use do not arise. __ are contractually binding upon the parties.167.A mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Designed to benefit the sponsor by achieving an expected outcome or product.What is a contract?168.Members of an Institutional Animal Care and Use Committee (IACUC) must be appointed
a. funding agency program officer
b. Office of Human Research Protection
c. responsible administrative official of the organization
d. research administrator responsible for the committeec. responsible administrative official of the organization
169.Member unaffiliated with the institutionAccording to federal regulations, which of the following must be included in an Institutional Review Board?170.minimum wages, maximum hours, child labor, convict labor and safe and sanitary working conditionsThe Walsh-Healey Public Contracts Act deals with issues on171.Modified total direct costIs a frequently used base for facilities and administrative cost (F&A) computation?172.modular budget is applicable only to R01, R03, R15, R21, and R34 applicationsIn an NIH Research Project Grant Program, which budget couldn't be over $25,000 in direct cost per year?173.The National Institutes of Health requires a written description of a program for providing instruction in the responsible conduct of research for:
a. program project grants
b. competing research project grants
c. noncompeting research project grants
d. Institutional National Research Service Awardsd. Institutional National Research Service Awards174.National Library of MedicineWhich of the following is located within the National Institutes of Health175.The National Science Foundation indicates decisions on the funding of grant proposals should normally takea
a. 2-4 months
b. 6-9 months
c. 10-12 months
d. 18-24 monthsb. 6-9 months176.Needs/Problem statementIt should be a clear and concise statement of the problem you want to solve with grant funds.
177.NIH: What are the main types of awardsResearch Grants (R series)
Career Development Awards (K series)
Research Training and Fellowships (T & F series)
Program Project/Center Grants (P series)178.NIH: What is Just-in-TimeRefers to the information that NIH will ask you to send after your application goes through initial peer review and is within the range of possible funding. NIH will need this information but does not require it with your application.179.Nondisclosure AgreementA Local Business wants to meet with a PI to discuss a product that they might agree to begin work on. What should be done?180.A Notice of Award typically includes which of the following?
a. Approval of facilities and administrative costs (Indirect Costs) rate
b. Award terms and conditions
c. Congressional approval
d. Guarantees for continuationb. Award terms and conditions181.Nuclear Regulatory CommissionStandards for handling radioactive materials are developed and monitored by the182.October 1The federal fiscal year begins:183.The Office and Grants and Contracts/Finance will monitor and draw cash on expenditures as appropriateThe university receives a grant from NIH that states the payment terms are DHHS Letter of Credit. This means:184.The office for Human Research Protection is administered by:
a. a private agency
b. a nonprofit foundation
c. an independent federal agency
d. a cabinet-level departmentd. a cabinet-level department
185.Office supplies, postage, administrative and clerical salaries, local telephone charges and general purpose equipmentThe following items should normally be treated as F&A cost except when the particular cost item can be justified as an exceptional need. What are some examples of exceptional need186.OMB Circular A-133The following establishes audit requirements and defines Federal responsibilities for implementing and monitoring these requirements for institutions of higher education and other nonprofit institutions receiving federal awards187.On an SF 424 Form, what does renewal, mean?requests additional funding for a period subsequent to that provided by a previous award and competes with all other applications.188.On an SF 424 Form, what does resubmission mean?has been previously submitted, but was not funded and is now being resubmitted.189.On an SF 424 Form, what does revision mean?proposes a change in 1) the Federal government's financial obligations or contingent liability from an existing organization, or 2) any other changes in the terms and conditions of the existing award, including requests for additional specific aims.190.Once each calendar year and is issued on a quarterly basisThe CFR is divided into 50 titles that represent broad areas subject to regulation and is published by the Federal executive agencies/departments. Each volume of the CFR is updated191.Payments to subjectsWhich of the following costs is allowable according to OMB Circular A-21?192.personnel salaries are increasedPrior approval from a federal agency is usually not needed when
193.The PHS policy governing the use and care of animals covers
a. live, vertebrate animals only
b. any animal use in research and training
c. animals involved in research only
d. animals that might otherwise be kept as pets onlya. live, vertebrate animals only194.PlagiarismThe appropriation of another person's ideas, processes, results, or words without giving appropriate credit195.A plan for expenditure of fundsWhich of the following must be included in every federal grant budget?196.Possible items could NIH request through Just-in-timeOther support Current and Pending, Certificate of IRB approval of proposed use of human subjects , Evidence of compliance with education in the protection of human subjects ,Verification of IACUC approval of proposed use of live vertebrate animals197.Primary purpose of a federal cooperative agreementTo provide assistance with substantial involvement of the federal agency198.prior actual costA facilities and administrative cost (indirect cost) rate is usually established based on
199.Prior approval from a federal agency is usually NOT needed when:
a. the scope of work is changed
b. personnel salaries are increased
c. the principal investigator is changed
d. additional alterations costing more than $10,000 are madeb. personnel salaries are increased200.Prior intramural support should be addressed in the narrativeWhen applying for extramural support, in which of the following ways should the principal investigator address prior related intramural support?201.PrisonersWhich of the following populations has special protection as research participants under federal guidelines?202.Prisoners, pregnant women, mentally unstable, and minors.Who cannot participate in clinical trials203.Privacy Act of 1974When an agency contracts for the design, development, or operation of a system of records on individuals on behalf of the agency to accomplish an agency function, the agency must apply the requirements of which of the following acts204.Project travelWhich of the following is NOT included in the computation of an indirect cost rate205.Proposal Central or Foundation web site.What resource site do Private Foundations mostly submitted through?206.Proposal SolicitationRFP and RFA are examples of207.protection provided to the authors of "original works of authorship" including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublishedWhat is a copyright?208.protects certain health information and requires naming a Privacy Official and written policy and procedures.What is the Health Insurance Portability and Accountability Act (HIPPA) Patient Privacy Rule?
209.protects people from discrimination based on sex in education programs or activities which receive Federal financial assistanceWhat is Title IX of the Education Amendments: Sex Discrimination?210.Protects the rights of employees and employers. Encourages collective bargaining. And curtails certain private sector labor and management practices, which can harm the general welfare of workers, businesses and the US economy.What is the National Labor Relations Act?211.Provides an entitlement of up to 12 weeks of job-protected, unpaid leave funding any 12-month period for the following reasons; birth and care of the employees child, or placement for adoption or foster care of a child with the employees; care of an immediate family member who has a serious health condition or care of the employees own serious health condition.What is the Family and Medical Leave Act?212.Provides labor standards for certain persons employed by federal contractors over $2500 furnishing services to federal agencies.What is the Service Contract Act?213.Provisions are intended to help secure the nation against bioterrorism acts.The act requires individuals and institutions to nor produce, acquire, retain (stockpile) or possess types and quantities of any biological materials including bona fide research.What is the US Patriot Act?214.provisions for an organizational program for the care and use of animalsEach organization using animals in Public Health Service sponsored projects must provide written assurance of its compliance with215.RebudgetingFederal expanded authorities permit which of the following without additional sponsored approval?
216.received from any funding sourceCost Accounting Standards (CAS) must be applied to awards217.The recipient of federal funds agrees that US flag air carriers will be used to transport personnel and property when costs are charged to these funds including any air transportation to from between or within a country other than the US when US flag air carriers are available.What is the Fly America Act?218.Recipients of federal grant funds must retain records for a MINIUMUM of:
a. 180 days after closeout
b. 18 month after the grant end date
c. 2 years after each grant budget year
d. 3 years from submission of final report of expenditured. 3 years from submission of final report of expenditure219.Refer employee to appropriate institution representativeWhich of the following is an appropriate response to sexual harassment reported by an employee in the work force?220.Regular dissemination of funding opportunitiesWhich of the following is most important in developing a program of available support with a grantee institution?221.The Regulation imposes a 6-year time limitationWhat is the time limitation for occurrences of research misconduct to be brought to the attention of an institution or the Department of Health and Human Services (HHS) (see § 93.105)222.remain with the institutionUnder federal grant conditions, the title to equipment must223.RentWhich would you charge against F&A?224.Rental or usage fees from equipment purchased with grant fundsWhich of the following is considered program income?
225.Request a one year, no cost extension of the grant while a revised continuation is under preparationA faculty member has a five year National Institutes of Health (NIH) grant which will terminate August 31, with $14,000 remaining on July 15 of the same year. A competing continuation was recommended for approval but not funded. Which of the following is the most appropriate advice for the research administrator to give to the faculty member?226.Required information on federal awards be made available to the public via single, searchable websiteWhat is the Federal Funding Accountability and Transparency Act (FFATA)?227.Requires employers to assure that employees hired are legally authorized to work in the US.What is Immigration Reform and Control Act (IRCA)?228.Requires the government to show 3 materials elements on all sole source contracts with a the current threshold applicable to all agencies is $700,000 for prime contracts awardedWhat is Truth in Negotiations Act?229.Research misconductWhat is defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion230.responsible administrative official of the organizationMembers of an Institutional Animal Care and Use Committee (IACUC) must be appointed by the231.Responsible Conduct of Research (RCR).What process was created from America COMPETES act?232.Restricts the political activity of executive branch employees of the federal government, District of Columbia government, and some state and local employees who work in connection with federally funded programsWhat is the Hatch Act?233.Returned to the sponsoring agencyUpon completion of a federal grant, excess funds remaining in the account should be
234.RFPWhich of the following would serve the purpose of inviting proposals and specifying the general terms and conditions under which the relevant award can be made235.Roles and responsibilities of the Principal Investigator and other key personnelProper technical conduct of the research effort
Compliance with the terms and conditions of the sponsored agreement, Managing project funds within the approved budget
Timely completion and submission of required technical reports
Complying with all university and sponsor policies and procedures pertinent to the award236.Roles and responsibilities of the Sponsored Programs OfficeProviding accounting, Purchasing
Other administrative services to assist the principal investigators in: - managing the financial aspects of their projects
obtaining the necessary goods, services, and personnel to conduct the research effort, meeting sponsor needs for fiscal reports, Provides financial accounting to sponsors for the activity funded and is subject to federal audit.237.a royalty-free, nonexclusive, and irrevocable licenseFor copyrighted works which result from federally sponsored activities, the federal government usually requires238.Salaries and wagesWhich of the following is a base for facilities and administrative cost (indirect rate)?239.Salary or other payments for service, equity interests, intellectual property rights.Significant Financial Interest is defined by the regulation as anything of monetary value, including but not limited to:240.SF269The following is used to prepare quarterly, semi-annual, annual, or end reports241.SF270The following is used to request for an advance or reimbursement242.SF272The following is used to prepare a report of federal cash transactions243.Shelby AmendmentAccess to federally funded research data is required under the244.Should be closely followedWhich of the following is most appropriate use of federal agency guidelines for writing a proposal245.SponsorWhich of the following is responsible for clinical trial registration on ClinicalTrials.gov?
246.Standards for handling radioactive materials are developed and monitored by the:
a. Nuclear Regulatory Commission
b. Environmental Protection Agency
c. Centers for Disease Control and Prevention
d. Occupational Safety and Health Administrationa. Nuclear Regulatory Commission247.State and local governments are subject to which of the following OMB Circulars?
a. 2 CFR 220 (A-21)
b. A-102
c. 2 CFR 230 (A-122)
d. A-133b. A-102248.Subcontractor onlyIn the event of a cost overrun by a subcontractor, who would be held responsible by the funding source?249.Subcontractor's normal rateWhich of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract?250.Subcontract, Subgrant, or SubagreementA document written under the authority of, and consistent with the terms and conditions of an award, that transfers a portion of the research of substantive effort of the prime award to another institution or organization.251.System for Award Management (SAM)What is the name of the system for requiring submission and maintenance of representations and certifications252.Task Order Agreement TOAA legally binding document authorizing work and appropriating funds as a supplement to a basic contact.
253.teaching abroadThe Fulbright Program provides opportunities for254.Teaming AgreementAn agreement between two or more parties to participate in a research project or teaching activity255.Temporary rate subject to final negotiationWhich of the following best describes a provisional indirect cost rate256.They upload it to their submission application. Not on the SF 424 formIf a PI wants to request a reviewer to a proposal submission, where can they do this257.TitleIt should tell us in 25 words or less what you intend to research and should be relevant258.TravelWhich of the following expenses would be included in the distribution base of modified total direct costs?259.The travel costs do not provide any benefit to the federally sponsored projectA PI on a federally awarded grant wants to charge travel costs to a project for attendance at a conference that is unrelated to the project. Which of the following BEST explains why the PI cannot charge the travel costs to the project260.treated under organization's policy as exempt from reviewIf a principal investigator proposes to conduct research involving human subjects who will take a standardized educational test, but the test will not include any names or other identifying information, the proposal should be261.TrueUBMTA may not be usable for materials in projects supported by industry. True or False262.TrueA one-time no-cost extension up to 12 months is allowed as an expanded authority. True or False263.twice a yearThe Institutional Animal Care and Use Committee (IACUC) is required to inspect animal facilities a MINIMUM of
264.Under a federal contract, which of the following is a reason for termination for default?
a. Untimely performance
b. Budget revision
c. Cost overrun
d. Inadequate performance on another contracta. Untimely performance265.Under federal grant conditions, the title to equipment must
a. remain with the agency
b. remain with the institution
c. be vested with the institution only under $5,000
d. be vested in the institution with the agency's right to transfer to itself or another entityb. remain with the institution266.Under which of the following conditions is a Certificate of Current Cost and Pricing required?
a. For a federal contract over $1,000,000
b. For any federal subcontractor
c. From any institution that received more than $500,000 in federal funding
d. As a standard of certification submitted by institutions applying for federal grantsc. from an institution that received more than $500,000 in federal funding267.Uniform Biological Material Transfer Agreement (UBMTA)Makes one class of transfers routine
Standard terms developed in 1995 by NIH sponsored group
Provides standardized approach for certain transfers between academic institutions
268.Unilateral AwardAn award made by a sponsored to an organization without considering competitive proposals. They are most often made when unsolicited proposals receive favorable treatment.269.United States Department of Agriculture (USDA)is the U.S. federal executive department responsible for developing and executing federal government policy on farming, agriculture, forestry, and food. It aims to meet the needs of farmers and ranchers, promote agricultural trade and production, work to assure food safety, protect natural resources, foster rural communities and end hunger in the United States and abroad.270.United States Department of Homeland Securitya cabinet department of the United States federal government, created in response to the September 11 attacks, and with the primary responsibilities of protecting the United States and its territories (including protectorates) from and responding to terrorist attacks, man-made accidents, and natural disasters.271.United States Department of Veterans Affairsis a government-run military veteran benefit system with cabinet-level status. It is the United States government's second largest department, after the United States Department of Defense.272.unlike circumstances are presentA facilities and administrative cost (indirect cost) may be a direct cost if273.Untimely performanceUnder a federal contract, which of the following is a reason for termination for default?
274.Upon completion of a federal grant, excess funds remaining in the account should be :
a. returned to the sponsoring agency
b. transferred to another sponsored project
c. assigned to institution's general funds
d. included in proposal for an additional granta. returned to the sponsoring agency275.Upon receipt of awarded projects, educational institutions are required to establish?
a. credit card account for the investigator
b. combined accounts for easier investigator access
c. noninstitutional savings account for the investigators
d. individual accounts in an approved accounting systemd. individual accounts in an approved accounting system276.U.S. Department of Justice, under the False Claims ActWhich federal agency is responsible for prosecuting institutional violations of effort reporting277.U.S. Department of StateInternational Traffic in Arms Regulations (ITAR) are controlled by the278.Using the criteria contained in 2 CFR 220 (OMB Circular A-21), which of the following costs would most likely be allowable as a direct expenditure item on a federal grant?
a. Costs of preparing the grant proposal
b. Break refreshments at a project-sponsored workshop
c. Facility rental for a project staff holiday party
d. An amount specifically set aside for unanticipated expensesb. Break refreshments at a project-sponsored workshop279.Varies with funding sourceFederal regulations require that documentation of expenditures must be kept for how long?280.verifiable from recordsCost sharing must be
281.A vivariumWhat is an area, usually enclosed, for keeping and raising animals or plants for observation or research282.What are allowable costsAre costs that can be legitimately charged to a grant. An award refers to those funds that have been obligated by a funding agency for a specific project.283.What are Research Administrators?Advocate, Facilitator, Gatekeeper, Reviewer, Enforcer, Motivator, Resource Locator, Interpreter,Team Builder,Compliance Manager284.What are the roles and responsibilities of the InstitutionExpedite hiring of staff and faculty to enable work to proceed from the start of the award; Assist departments, schools, the Office of Research, and the Office of Research Accounting to facilitate administrative tasks; Meet the terms and conditions of the sponsored award in collaboration with the Investigators;-Provide timely and accurate monthly accounting reports to Investigators285.What determines if Financial Interest is SignificantFunds received for investigator and spouse/children meets both the following tests: 1) does not exceed $5000 in value as determined through reference to public prices or other reasonable measures of market value 2) does not represent more than a 5% ownership interest in any single entities.286.What is a Commercial And Government Entity Code (CAGE) and its purposeis a unique identifier assigned to suppliers to various government or defense agencies, as well as to government agencies themselves and also various organizations. It provide a standardized method of identifying a given facility at a specific location.287.What is a Data Universal Numbering System (DUNS Number)?is a system developed and regulated by Dun & Bradstreet that assigns a unique numeric identifier to a single business entity. That number is a nine-digit number issued to each business location in the D&B database having a unique, separate, and distinct operation for the purpose of identifying them.288.What is a grant?A type of financial assistance awarded for the conduct of research and no substantial programmatic involvement with the recipient during the performance of the activities.289.What is an Invitation For Bid (IFB)?the method used for the sealed bid process. A contract is then awarded to the low bidder whose bid conforms with all requirements of the invitation and will be advantageous to the government in terms of price, and price-related factors
290.What is a Request for Proposal (RFP)?occurs when the agency isn't certain about what it wants and is looking to you to develop a solution and cost estimate.291.What is a Request for Quote (RFQ)is often used to determine current market pricing, but is not a binding offer and can't be accepted by the government. A Standard Form 26, which requires the signatures of both the contractor and the contracting officer, would be required to make the offer binding.292.What is a Student Visa?Generally, a citizen of a foreign country who wishes to enter the United States must first obtain a visa, either a nonimmigrant visa for temporary stay, or an immigrant visa for permanent residence. You must have a student visa to study in the United States. Your course of study and the type of school you plan to attend determine whether you need an F-1 visa (academic) or an M-1 visa (vocational).293.What is Catalog of Federal Domestic Assistance (CFDA)?is a government-wide compendium of an online database listing all available federal programs.294.What is debarment?removes you as a contractor from eligibility for future government contracts for a fixed period of time.295.What is Drug Free Work ForceDOD contractors must maintain records regarding drug-free work force programs provided to their employees. Also establishes a program testing for the use of illegal drugs by employees.296.What is effort reportingThe percentage of total employment devoted to a particular project, activity, administrative task297.What is Equal Employment Opportunity?provide equal opportunity without regard to race, color, religion, sex, or nationality to persons employed or seeking employment298.What is Fair Labor Standards Act?Enacted to establish a minimum hourly wage, overtime pay and regulate child labor299.What is Health Resources and Services Administration (HRSA) and who do they fall underimproves access to healthcare for people who are uninsured, isolated, or medically vulnerable and under DHHS.
300.What is Lobbyingthe act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies.301.What is Small Business Innovative Research (SBIR)?refers to the agency administered programs that are supported by ear-marked federal funds, making grants to small business entities302.What is Small Business Technology Transfer (STTR)?refers to the grant applications and/or programs for funding those small business that are teamed up with research institutions.303.What is suspension?temporarily debars a contractor for the duration of any agency investigation of the contractor or ensuing legal proceedings.304.What is the America COMPETES Act?America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science- focuses on increasing research investment
Strengthens STEM Research (science, technology, engineering and math) from elementary through grad school.305.What is the Buy America Act?Establish a general preference for domestic articles, materials/supplies to protect the American worker by saving and creating jobs.306.What is the Byrd Amendment?Institution must certify that no appropriated funds were or will be expended to pay any person for influencing or attempting to influence an officer or an employee of any agency, a member of Congress, an officer or employee of Congress in connection with a specific award.307.What is the Civil Rights Act?Bars recipients of federal funds from excluding persons because of race, sex, color, or national origin from participation in receiving benefits or otherwise subjecting them to discrimination under federally supported programs or activities. Law also interpreted to cover discrimination against those persons with limited English. Sex includes pregnancy, childbirth or related medical conditions.308.What is the Confidentiality of Patient Records?Enacted to protect persons with substance abuse problems who seek treatment.309.What is the Davis/Bacon ActRequires contractors to pay wages to laborers and mechanics at a rate of no less than a minimum wage specified in a wage determination made by the Secretary of Labor.
310.What is the Drug Free Workplace ActIt says you can't receive federal funding if you do not have a drug-free workplace policy in place311.What is the Endangered Species Act?species listed as endangered or threatened prohibits the unauthorized taking, possession, sale and transport of those species312.What is the Equal Pay Act?act prohibits employers and unions from paying different wages based on the employees sex313.What is the False Claims Act?Improper costing, product substitutions, failure to comply with contract specifications and filing false claims with government health care programs314.What is the percentage that all STTR budgets must matchAt least 40 percent of the STTR research project is to be conducted by the small business concern and at least 30 percent of the work is to be conducted by the single "partnering" research institution.315.What is the Ruth L. Kirschstein NSRA Award? Why is it importanttrain fellows and residents, and are used to promote the education of future researchers. She was a champion of research training and a strong advocate for the inclusion of underrepresented individuals in the scientific workforce316.What is the Solomon Act (Amendment)/ National Defense Authorization ActWhat United States federal law that allows the Secretary of Defense to deny federal grants (including research grants) to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus.317.What is use of name exceptionIt's an exception that agree that neither party will use directly or by implication names or trademarks of the other party in connection with any publicity, promotion or advertising without prior written approval.318.What is voluntary committed cost sharing?when the proposing institution volunteers and commits to bear a specific portion of the costs of the project when it is not required.319.What is voluntary uncommitted cost sharing?when the PI chooses to expend some unspecified amount of effort more than proposed towards the award. This is usually the case when the PI is not requesting salary from the award, and so is volunteering his/her effort.
320.When applying for extramural support, in which of the following ways should the PI address prior related support?
a. Prior intramural support should be ignored
b. Prior intramural support can be considered as an item of cost sharing in the budget narrative
c. Prior research related support should be considered unrelated in current grant request
d. Prior intramural support should be addressed in the narratived. Prior intramural support should be addressed in the narrative321.When a subaward is involved in a federal grant to a large university, on what portion of the subawardee's budget does the prime institution recover facilities and administrative costs (indirect costs)?
a. None of it
b. The first $25,000
c. The subawardee's modified total direct cost amount
d. The amount is excess of $25,000b. The first $25,000322.Whenever covered animals are involved in a protocolWhich of the following requires Institutional Animal Care and Use Committee (IACUC) review and approval governing the use of animals?323.When granted expanded authorities pre-award costs on a federal grant may be incurred by an institutional within
a MAXIMUM of how many days prior to the official start date:
a. 30 days
b. 45 days
c. 90 days
d. 120 daysc. 90 days
324.Which federal agency is responsible for prosecuting institutional violations of effort reporting?
a. U.S. Department of Justice, under the False Claims Act
b. Government Accountability Office, under the Code of Federal Regulations
c. Office of Management and Budget, under OMB Circular A-133 Audit Requirements
d. National Science Foundation Office of the Inspector General, under Congressional Oversight Authoritya. U.S. Dept of Justice, under the False Claims Act325.Which of the following agencies does NOT fund health science research?
a. U.S. Army
b. Department of Energy
c. National Institute of Aging
d. National Science Foundationd. National Science Foundation326.Which of the following agencies is responsible for administering the Animals Welfare Act?
a. Public Health Service
b. Department of Agriculture
c. Environmental Protection Agency
d. American Society for Prevention of Cruelty to Animalsb. Department of Agriculture327.Which of the following are two critical termination clauses of General Provisions of a federal contract:
a. Dispute and changes
b. Default and convenience
c. Default and stop work order
d. Stop work order and failure to confirmb. Default and convenience
328.Which of the following best describes 2 CFR 220 (OMB Circular A-21)?
a. Is applicable only to NSF and NIH
b. Allows federal agencies to places additional restrictions on individual items of costs
c. Deals with cost determination but does not identify the circumstances or dictate the participation in the financing of a project
d. Establishes principles for determining costs applicable to contracts, grants, and other agreements with both educational institutions and hospitalsc. Deals with cost determination but does not identify the circumstances or dictate the participation in the financing of a project329.Which of the following best describes federal regulations governing the use of humans in research?
a. Allow the researcher full discretion as to what to include in informed consent materials
b. Always require full informed consent on the subject or the subject's guardian
c. Allow the Institutional Review Board discretion in limited situations to approve protocols providing less than full informed consent
d. Waive full informed consent of the subject when the protocol is too complicated for an individual subject to understand the risksb. Always require full informed consent on the subject or the subject's guardian330.Which of the following delegates to grantee authorization of one year, no-cost extensions?
a. Expanded Authorities
b. Cost Accounting Standards
c. Public Law 106-107
d. Code of Federal Regulationsa. Expanded Authorities331.Which of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract?
a. Prime recipient's rate
b. Prime award agreement
c. Subcontractor's normal rate
d. Agreement between subcontractor and funding agencyc. Subcontractor's normal rate
332.Which of the following expenses would be include in the distribution base of modified total direct costs?
a. travel
b. equipment depreciation
c. sponsored programs office expenses
d. the portion of each subcontract in excess of $25,000b. equipment depreciation333.Which of the following information must be included in the notification by a federal officer to the contractor to terminate a contract for convenience?
a. Signature of program office
b. The effective date of the contract
c. A citation of the contract clause authorizing the termination
d. A specific statement defining the reason for the termination noticed. A specific statement defining the reason for the termination notice334.Which of the following involves a conflict of interest?
a. Faculty member owns and operates a business outside of university commitment
b. Faculty member consults with outside business in area of expertise
c. Faculty member supervises students employs them in university sponsored projects
d. Faculty member is a major stockholder in a for-profit company receiving a university contractd. Faculty member is a major stockholder in a for-profit company receiving a university contract335.Which of the following is a base for facilities and administrative costs (indirect costs)?
a. Subcontracts
b. Capital Equipment
c. Salaries and wages
d. Professional and outside servicesc. Salaries and wages336.Which of the following is a frequently used base for facilities and administrative costs (indirect cost) computations
a. Nonsalary costs
b. Capitalized equipment
c. Modified total direct cots
d. Total direct costs less pre-award costsc. Modified total direct cots
337.Which of the following is allowable as cost sharing?
a. Equipment donated at fair market value
b. Alcohol purchased for an allowable business dinner
c. A portion of the salary of the department head's secretary
d. Travel costs in excess of institutional per diema. Equipment donated at fair market value338.Which of the following is a primary purpose of a federal cooperative agreement?
a. To allow for flexible budgeting
b. To provide assistance with few restrictions
c. To enable solicitation by a Request of Proposal
d. To provide assistance with substantial involvement of federal agencyd. To provide assistance with substantial involvement of federal agency339.Which of the following is essential to a Clinical Hygiene Plan?
a. Material Safety Data Sheet (MSDS) file
b. Monthly fire and safety drills
c. Public information program
d. Federal Food & Drug Administration inspectiona. Material Safety Data Sheet (MSDS) file340.Which of the following is included in 2 CFR 215 (OMB Circular A-110)?
a. Audit requirements
b. Debarment and suspension rules
c. Federal contact requirements
d. Cost principles for nonprofitsb. Debarment and suspension rules341.Which of the following is located within the National Institutes of Health?
a. National Library of Medicine
b. Centers for Disease Control and Prevention
c. Food and Drug Administration
d. National Institute for Occupational Safety and Healtha. National Library of Medicine
342.Which of the following is mandated for the oversight of research involving recombinant DNA?
a. rDNA Committee
b. Biosafety Ethics Committee
c. Institutional Biosafety Committee
d. Institutional Biohazard Committeec. Institutional Biosafety Committee343.Which of the following is most important in developing a program of available support within a grantee institution?
a. Hiring of information specialist
b. Regular dissemination of funding opportunities
c. Development of subject-related database
d. Establishment of potential investigator fileb. Regular dissemination of funding opportunities344.Which of the following is responsible for clinical trail registration of Clinical Trials.gov?
a. Sponsor
b. Institution
c. Sponsored research office
d. Institutional Review Board (IRB)a. Sponsor345.Which of the following populations has special protection as research participates under federal guidelines?
a. Elderly
b. Prisoners
c. College Students
d. Persons diagnosed as HIV positiveb. Prisoners346.Which of the following requires Institutional Animal Care and Use Committee (IACUC) review and approval governing the use of animals?
a. When any animal is used
b. Only when laboratory animals are used in instruction
c. Whenever covered animals are involved in a protocol
d. Only if a protocol involve sacrificing animalsc. Whenever covered animals are involved in a protocol347.Which of the following sources in NOT commonly used for FEDERAL funding opportunites:
a. The Federal Register
b. The Foundation Directory
c. Commerce Business Daily
d. The Catalog of Federal Domestic Assistanceb. The Foundation Directory
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Premier Research Clinical Research Associate
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Syneos Health Clinical Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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PRA Health Sciences Clinical Research Associate
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Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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11 salaries
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Skills Alliance Clinical Research Associate - CRA Course
Clinical Research Associate Job available - CRA Course
$113,368 per year
Advanced Clinical Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
Clinical Research Associate Job available
$107,750 per year
Syneos Health Commercial Solutions Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
Clinical Research Associate Job available
$98,894 per year
Piper Companies Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
Clinical Research Associate Job available
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Novella Clinical Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
Clinical Research Associate Job available
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Covance Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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Premier Research Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
Clinical Research Associate Job available
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Syneos Health Clinical Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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$93,469 per year
PRA Health Sciences Clinical Research Associate
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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Novo Nordisk, Inc. Clinical Research Associate
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Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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AbbVie Clinical Research Associate - CRA Course
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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ICON plc Clinical Research Associate - CRA Course
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
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PAREXEL Clinical Research Associate - CRA Course
Requires CCRP Online CRA Training Program Certification (Completed in 4 Weeks; you can apply 2 weeks into the course).
Clinical Research Associate Job available
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QuintilesIMS Clinical Research Associate - CRA Course
11 salaries
Clinical Research Associate Job available
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MD Anderson Cancer Center Clinical Research Associate - CRA Course
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Chiltern International Clinical Research Associate - CRA Course
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$87,722 per year
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5 salaries
Clinical Research Associate Job available
$71,586 per year
University of Florida Clinical Research Associate - CRA Course
11 salaries
Clinical Research Associate Job available
$69,492 per year
Department of Veterans Affairs Clinical Research Associate - CRA Course
6 salaries
Clinical Research Associate Job available
$66,274 per year
Abbott Laboratories Clinical Research Associate - CRA Course
6 salaries
Clinical Research Associate Job available
$66,095 per year
University of Utah Clinical Research Associate - CRA Course
19 salaries
Clinical Research Associate Job available
$66,775 per year
University of Minnesota Clinical Research Associate - CRA Course
8 salaries
Clinical Research Associate Job available
$64,600 per year
University of Connecticut Health Center Clinical Research Associate - CRA Course
8 salaries
Clinical Research Associate Job available
$58,321 per year
St. Jude Children's Research Hospital Clinical Research Associate - CRA Course
6 salaries
Clinical Research Associate Job available
$56,315 per year
Northwestern University Clinical Research Associate - CRA Course
6 salaries
Clinical Research Associate Job available
$54,342 per year
Duke Clinical Research Institute Clinical Research Associate - CRA Course
5 salaries
$73,447 per year
Emory University Clinical Research Associate - CRA Course
5 salaries
Clinical Research Associate Job available - CRA Course
$50,778 per year
Medpace Clinical Research Associate
6 salaries
Clinical Research Associate Job available
$50,958 per year
University of South Florida Clinical Research Associate
20 salaries
Clinical Research Associate Job available
$50,810 per year
The University of Iowa Clinical Research Associate
26 salaries
Clinical Research Associate Job available
$43,547 per year
Yale University Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$40,378 per year
University of Maryland, Baltimore Clinical Research Associate
7 salaries
Clinical Research Associate Job available
$39,818 per year
University of North Carolina at Chapel Hill Clinical Research Associate
7 salaries
Clinical Research Associate Job available
$38,402 per year
University of North Carolina at Greensboro Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$38,475 per year
Virginia Commonwealth University Clinical Research Associate
19 salaries
Clinical Research Associate Job available
$36,453 per year
University of North Carolina Clinical Research Associate
15 salaries
$36,955 per year
University of Pittsburgh Clinical Research Associate
13 salaries
Clinical Research Associate Job available
$33,878 per year
SUNY Downstate Medical Center Clinical Research Associate
9 salaries
Clinical Research Associate Job available
$33,343 per year
Washington University in St. Louis Clinical Research Associate
18 salaries
Clinical Research Associate Job available
$15.75 per hour
UC San Diego Clinical Research Associate
19 salaries
Clinical Research Associate Job available
$4,353 per month
University of California - San Francisco Clinical Research Associate
6 salaries
Clinical Research Associate Job available
$100 per day
Real Staffing Clinical Research Associate
15 salaries
Clinical Research Associate Job available
$31.95 per hour
University of Nebraska Medical Center Clinical Research Associate
12 salaries
Clinical Research Associate Job available
$15.81 per hour
Texas Tech University Health Sciences Center Clinical Research Associate
6 salaries
Clinical Research Associate Job available
$3,609 per month
Aerotek Clinical Research Associate
8 salaries
$47.68 per hour
Randstad Clinical Research Associate
35 salaries
$45.90 per hour
Ohio State University Clinical Research Associate
124 salaries
Clinical Research Associate Job available
$14.49 per hour
University of Kentucky Clinical Research Associate
59 salaries
Clinical Research Associate Job available
$21.63 per hour
Biotech Partners Clinical Research Associate
12 salaries
Clinical Research Associate Job available
$111,431 per year
DOCS Global Clinical Research Associate
14 salaries
Clinical Research Associate Job available
$90,856 per year
CyberCoders Clinical Research Associate
28 salaries
$88,409 per year
Zp group Clinical Research Associate
18 salaries
$98,008 per year
CIG Clinical Research Associate
109 salaries
$116,784 per year
CorTech, LLC Clinical Research Associate
40 salaries
$38.91 per hour
Skills Alliance (Recruiting Company) Clinical Research Associate
12 salaries
$71.01 per hour
InfoStaff Clinical Research Associate
52 salaries
$109,699 per year
Stony Brook University Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$39,254 per year
Brio Resource Group Clinical Research Associate
46 salaries
Clinical Research Associate Job available
$129,987 per year
Planet Pharma Clinical Research Associate
7 salaries
Clinical Research Associate Job available
$117,458 per year
biorasi LLC Clinical Research Associate
18 salaries
$63,702 per year
Intermountain Home Care Clinical Research Associate
11 salaries
$15.55 per hour
Piper Clinical Solutions Clinical Research Associate
16 salaries
$64,853 per year
Personify Clinical Research Associate
36 salaries
$99,373 per year
Segal Trials Clinical Research Associate
24 salaries
$2,195 per month
Bertram & Associates Clinical Research Associate
7 salaries
$116,417 per year
Lodestar Executive Search Clinical Research Associate
7 salaries
$116,417 per year
PSU Personnel Services Unlimited, Inc. Clinical Research Associate
6 salaries
$104,485 per year
The Hastings Group Clinical Research Associate
7 salaries
$116,417 per year
Ploeger Recruiting Services Clinical Research Associate
6 salaries
$104,485 per year
Phillips Staffing Solutions Clinical Research Associate
6 salaries
$104,485 per year
PMG Employment Consultants Clinical Research Associate
7 salaries
$116,417 per year
Bio-Partners Clinical Research Associate
7 salaries
$116,417 per year
Hire Horizons Clinical Research Associate
6 salaries
$104,485 per year
SearchStars Clinical Research Associate
6 salaries
$104,485 per year
Fowler Placement Services, Inc. Clinical Research Associate
6 salaries
$104,485 per year
Plastic Executive Recruiters Clinical Research Associate
6 salaries
$104,485 per year
EPM Scientific Clinical Research Associate
13 salaries
Clinical Research Associate Job available
$98,268 per year
Barrington James Clinical Research Associate
12 salaries
Clinical Research Associate Job available
$124,820 per year
MedExec International Clinical Research Associate
6 salaries
$104,485 per year
Tri-Force Clinical Research Associate
7 salaries
$116,417 per year
Professional Recruiting Partners, LLC Clinical Research Associate
7 salaries
$116,417 per year
Career Brokers, Inc. Clinical Research Associate
6 salaries
$104,485 per year
Helffrich International Clinical Research Associate
6 salaries
$104,485 per year
Tailored Management Clinical Research Associate
10 salaries
$79,138 per year
MJ Recruiters, LLC Clinical Research Associate
6 salaries
$104,485 per year
Meet Recruitment Clinical Research Associate
12 salaries
$102,820 per year
University of Virginia Clinical Research Associate
16 salaries
Clinical Research Associate Job available
$44,455 per year
Medical University of South Carolina Clinical Research Associate
20 salaries
Clinical Research Associate Job available
$32,233 per year
Oregon Health Sciences University Clinical Research Associate
17 salaries
Clinical Research Associate Job available
$43,176 per year
AutoPro Technical Recruiting Clinical Research Associate
6 salaries
$104,485 per year
MMS Group Clinical Research Associate
6 salaries
$104,485 per year
ONESource Technical Clinical Research Associate
6 salaries
$104,485 per year
Technology Recruiting Solutions, Inc. Clinical Research Associate
6 salaries
$104,485 per year
BRUNEL CANADA Clinical Research Associate
20 salaries
$83,573 per year
Affinity Executive Search Clinical Research Associate
20 salaries
$111,284 per year
PPD Development, L.P. Clinical Research Associate
11 salaries
$92,737 per year
HireNetworks Clinical Research Associate
12 salaries
Clinical Research Associate Job available
$94,478 per year
CMC Limited Clinical Research Associate
13 salaries
$111,719 per year
CMD And Associates Clinical Research Associate
17 salaries
$97,982 per year
fulltimeGiGS Clinical Research Associate
10 salaries
$120,496 per year
Cameron Craig Group Clinical Research Associate
17 salaries
$88,715 per year
Prevalent Group Clinical Research Associate
17 salaries
$95,522 per year
True North Consultants Clinical Research Associate
6 salaries
$104,485 per year
Financially Stable Pharmaceutical Clinical Research Associate
8 salaries
$112,472 per year
JDP Search Group Clinical Research Associate
16 salaries
$99,326 per year
PeopleStaff Clinical Research Associate
15 salaries
$84,270 per year
Clinical Management Consultants Clinical Research Associate
9 salaries
Clinical Research Associate Job available
$115,881 per year
JOHNLEONARD Clinical Research Associate
8 salaries
Clinical Research Associate Job available
$61,509 per year
Rangam Consultants Inc. Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$72,617 per year
Keshav Consulting Solutions Clinical Research Associate
13 salaries
$60,670 per year
Onboard.jobs Clinical Research Associate
15 salaries
$94,156 per year
Cor-Tech LLC Clinical Research Associate
15 salaries
$42.97 per hour
Klinexa Inc. Clinical Research Associate
8 salaries
$25.00 per hour
Systematic business consulting Clinical Research Associate
13 salaries
$88,299 per year
University of Miami Miller School of Med Clinical Research Associate
8 salaries
$74,809 per year
Global Channel Management, Inc. Clinical Research Associate
12 salaries
$41.26 per hour
Productive Data Solutions, INC. Clinical Research Associate
8 salaries
Clinical Research Associate Job available
$27.00 per hour
Selective Staffing Solutions Clinical Research Associate
8 salaries
Clinical Research Associate Job available
$19.49 per hour
Atlanta Center for Medical Research Clinical Research Associate
5 salaries
$33,642 per year
DOCS Clinical Research Associate
10 salaries
$78.22 per hour
Impact Business Group Clinical Research Associate
12 salaries
$54.45 per hour
CPS Recruitment Clinical Research Associate
7 salaries
$28.46 per hour
SCOPE International USA, Inc. Clinical Research Associate
11 salaries
$80,886 per year
Interview with Center for Advanced Obstetrical Care and Research Clinical Research Associate
8 salaries
$17.00 per hour
Inflamax Research Inc. Clinical Research Associate
6 salaries
$2,900 per month
Priority Sales Recruiting Clinical Research Associate
11 salaries
$108,226 per year
University of Texas Medical Branch Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$16.50 per hour
Eastern Virginia Medical School Clinical Research Associate
10 salaries
Clinical Research Associate Job available
$82,730 per year
Computech Corporation Clinical Research Associate
7 salaries
$45.00 per hour
Details on application Clinical Research Associate
9 salaries
$205,058 per year
BK Rich Associates Clinical Research Associate
6 salaries
$90,000 per year
Central Florida Careers Clinical Research Associate
9 salaries
$16.93 per hour
Chipton Ross Clinical Research Associate
10 salaries
$34.37 per hour
AppleOne Clinical Research Associate
10 salaries
$75,534 per year
Sabio Systems Clinical Research Associate
9 salaries
$19.90 per hour
Blair Search Clinical Research Associate
7 salaries
$116,417 per year
Sponsor Pharmaceutical company Clinical Research Associate
9 salaries
$110,000 per year
Helix Biomedics LLC Clinical Research Associate
6 salaries
$12.00 per hour
Ability Professional Network Clinical Research Associate
9 salaries
$95,663 per year
Leading CRO Company!! Clinical Research Associate
5 salaries
$99,504 per year
The Pursell Group Clinical Research Associate
7 salaries
$116,417 per year
PeaceHealth Clinical Research Associate
9 salaries
$35.36 per hour
new england physician recruitment center-boston Clinical Research Associate
9 salaries
$180,000 per year
MBA IT Consulting Services, Inc. Clinical Research Associate
7 salaries
$116,417 per year
Food Management Search Clinical Research Associate
7 salaries
$116,417 per year
Pharmaceutical Organization Clinical Research Associate
8 salaries
$246,884 per year
Texas Tech University Health Sciences Center of El Paso Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$15.64 per hour
University of Wisconsin–Madison Clinical Research Associate
8 salaries
Clinical Research Associate Job available
$40,257 per year
Careers 2005 Clinical Research Associate
6 salaries
$104,485 per year
Taylee Staffing Clinical Research Associate
8 salaries
$102,227 per year
Rayco Technical Solutions, LLC Clinical Research Associate
6 salaries
$104,485 per year
Nishom Pharma Corp Clinical Research Associate
6 salaries
$70,000 per year
5 salaries
$57,250 per year
Real Life Sciences Clinical Research Associate
7 salaries
$117,035 per year
Inflamax Research Clinical Research Associate
6 salaries
$2,900 per month
Aptude Inc. Clinical Research Associate
7 salaries
$20.00 per hour
Virginia Commonwealth University Clinical Research Associate
8 salaries
Clinical Research Associate Job available
$36,729 per year
Scientific Search Clinical Research Associate
7 salaries
Clinical Research Associate Job available
$85,322 per year
ER Squared, Inc. Clinical Research Associate
6 salaries
$50,000 per year
Valesta Clinical Research Solutions Clinical Research Associate
7 salaries
$65,000 per year
On-Board Services Clinical Research Associate
5 salaries
$38.67 per hour
Military4Hire Clinical Research Associate
6 salaries
$104,485 per year
SSC Clinical Research Associate
8 salaries
$115,000 per year
Enterprise Search Associates Clinical Research Associate
6 salaries
$104,485 per year
The Fountain Group Clinical Research Associate
8 salaries
$135,000 per year
VetPharm, Inc. Clinical Research Associate
8 salaries
$47,500 per year
Pioneer Data Systems, Inc. Clinical Research Associate
7 salaries
Clinical Research Associate Job available
$50.00 per hour
The University of Michigan Clinical Research Associate
6 salaries
Clinical Research Associate Job available
$60,183 per year
North Peak Recruiting Clinical Research Associate
6 salaries
$104,485 per year
MedicusTek USA, Inc Clinical Research Associate
7 salaries
$42,000 per year
Genesis Global Management Corporation Clinical Research Associate
7 salaries
$105,971 per year
Quality Clincial Research Clinical Research Associate
5 salaries
$28,802 per year
The Job Jobber Clinical Research Associate
7 salaries
$88,043 per year
IMARC Research, Inc. Clinical Research Associate
5 salaries
$15.52 per hour
PHAIDON INTERNATIONAL Clinical Research Associate
6 salaries
$109,198 per year
Experis Clinical Research Associate
7 salaries
$38.63 per hour
Sunrise Systems Clinical Research Associate
7 salaries
$29.69 per hour
Small Niche CRO! Clinical Research Associate
6 salaries
$88,364 per year
University of Toledo Clinical Research Associate
5 salaries
$66,079 per year
Resource Employment Solutions Clinical Research Associate
6 salaries
$24.04 per hour
RELODE Clinical Research Associate
6 salaries
$5,000 per month
Painter & Associates Personnel Clinical Research Associate
6 salaries
$104,485 per year
Provident Research Inc Clinical Research Associate
6 salaries
$113,374 per year
RBW Consulting Solutions Ltd Clinical Research Associate
5 salaries
$109,280 per year
ParkPower Corporation Clinical Research Associate
5 salaries
$120,496 per year
Acara Solutions Clinical Research Associate
5 salaries
$19.80 per hour
Essentia Health Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$16.73 per hour
New York State Psychiatry Institute Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$45,068 per year
BRIDGEWAY COMMERCE GROUP Clinical Research Associate
5 salaries
$120,496 per year
NuWest Group Clinical Research Associate
5 salaries
$16.43 per hour
Pharmaceutical Clients Clinical Research Associate
5 salaries
$30.00 per hour
Byrnes and Rupkey, Inc. Clinical Research Associate
5 salaries
$120,496 per year
Cap & Sol Clinical Research Associate
5 salaries
$50.00 per hour
RCTS, Inc Clinical Research Associate
5 salaries
$13.15 per hour
All US Jobs Clinical Research Associate
5 salaries
$120,000 per year
The DAVIS Companies Clinical Research Associate
5 salaries
$25.00 per hour
JGB BioPharma Consulting Inc. Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$112,945 per year
Advanced Technology Solutions Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$43.55 per hour
Worldwide Clinical Trials Holdings, Inc. Clinical Research Associate
5 salaries
$109,545 per year
Private Practice Leadership, LLC Clinical Research Associate
5 salaries
$15.71 per hour
Team1Medical Clinical Research Associate
5 salaries
$33,786 per year
ZEISS Group Clinical Research Associate
5 salaries
$48.00 per hour
Worldwide Placement Limited Clinical Research Associate
5 salaries
$90,000 per year
Pharmaceutical Research Associates, Inc. Clinical Research Associate
5 salaries
$76,530 per year
Healthcare Recruiters International Clinical Research Associate
5 salaries
$62,430 per year
Bridgeway Professionals Clinical Research Associate
5 salaries
$120,496 per year
i-Pharm Consulting Clinical Research Associate
5 salaries
Clinical Research Associate Job available
$94,767 per year
Collaborative Clinical Research Associate
5 salaries
$39.65 per hour
The Veritas Healthcare Solutions LLC Clinical Research Associate
5 salaries
$78,850 per year
Louis Stokes Cleveland VA Medical Center Clinical Research Associate
5 salaries
$43,399 per year
Piper Enterprise Solutions Clinical Research Associate
5 salaries
$111,929 per year
Groupware Solutions Clinical Research Associate - CRA Course
5 salaries
$30.00 per hour
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
How to Become a CRA in Canada: Clinical Research Associate Certification
How to Become a CRA in Canada
How to Get A Clinical Research Associate Certificate Online in Canada
CCRPS offers Canadian CRA certification for students living and working in Canada. A CRA certification in Canada provides students with additional knowledge of resources and guidelines in order to work in clinical research.
Our certification specifically state and prove that you have reviewed Canadian guidelines in clinical research and meet the competencies required for all clinical research associates.While our certificate is accredited by the ACCRE, 4 other organisations, and shows employers you have the working knowledge to act as a CRA; the CRAC credentialing exam will help further establish your professionalism. If you already have experience as a clinical research associate, you can use this course to prepare and sit for the CRAC examination.
In order to become a certified Canadian CRA, you must take the CRAC credentialing examination. To sit for the examination, you must fulfill one of these requirements:
2 years of clinical research expereience within the last 5 years
3,500 hrs of part time experience with at least 1 year of Canadian experience within the last 5 years
A post-graduate certificate in clinical research and at least 1 years’ experience over the past 2 years in clinical research. You must have at least 1 year of Canadian experience.
2. Clinical Research Associate Canada (CRAC) Membership
While CCRPS membership is free, you still benefit from obtaining CRAC membership even if you do not have enough experience to sit for the CRAC credentialing exam. Membership can create networking and job opportunities, as well as provide insight into the field. All interested professionals should become a Member of the Official Canadian CRA Association and list this involvement on their CV and cover letter.
3. CCRPS Canadian CRA Certification (CCRAC) for Resume Building
As we teach nearly 30 Canadian students each quarter, our Canadian Clinical Research Associate Certification will allow students to strengthen their application and resume, specifically towards Canadian guidelines and policies.
4. Landing A Entry Level Clinical Research Associate Job in Canada
Unfortunately, many professionals have trouble securing a job in order to get experience and take the CRAC exam. Our certification, specifically created for Canadian CRAs, provides entry-level science professionals with all the resources they need to be a working CRA in Canada. Our online exam can be taken at any time, if you enroll or demo our course.
5. Clinical Research Associate Programs in Canada
In addition to providing 130 modules, our CRA certification exam is priced affordably and the same as our American students. Students can gain valuable work experience by applying to be one of our CCRPS Clinical Research Education Fellows for a 1 month remote internship to develop and strengthen your resume.
6. Salary of Canadian Clinical Research Associate
Payscale Canadian CRA Salary
Payscale Canadian Pay Difference CRA
Clinical Research Certification Specifically for Canadian CRAs
CCRPS offers one of the only online certifications specifically designed for entry-level and mid-level professionals in clinical research associate knowledge. We prepare you to understand and apply all skills required to secure a job in clinical research.
Canadian Clinical Research Associate Certificate Course Preview
Want to Learn More About Clinical Research?
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course