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Clinical Research Project Manager

Clinical Research Project Manager - A Full Guide To Becoming a Clinical Trial Project Manager

As of mid-April 2022, top recruitment platform ‘indeed.com’ lists 6,026 openings for Clinical Research Project Managers across the United States[1]. According to ‘payscale.com’, remuneration for this profile ranges from $84,168 for early-career to $120,501 for experienced Clinical Research Project Managers, with a mid-career median of $107,649[2].

A Clinical Research Project Manager (henceforth CRPM) is also known as a Clinical Research Manager or a Clinical Trial Manager. The role of a CRPM is to provide leadership during the clinical trial of new drugs, with the overarching goal of ensuring that the clinical trials process is completed within the stipulated time-frame and allocated budget, while maintaining the highest standards of research quality and scientific integrity.

An overview of the CRPM profile

A Clinical Research Project Manager is the liaison between the study sponsor and the clinical research team. Thus, the CRPM must balance the expectations of the funding organization in a clinical research study (pharmaceutical company, governmental agency, university research division or other entity) with the needs of the team, including Principal Investigators (PIs) and co-PIs, Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs) and other site staff. 

The CRPM plays a leading role in planning, implementation and ongoing monitoring of live clinical trials. In the process, a CRPM also mentors junior team members, including CRAs and CTAs.

Evidently, a career as a CRPM is rewarding, but also demanding. So, what does it take to qualify and be recruited as a Clinical Research Project Manager?

The road-map to becoming a CRPM

Even if you’re new to the field of clinical research, you’ve probably guessed by now that becoming a Clinical Research Project Manager takes both qualifications and experience. A typical CRPM has a bachelor’s (or master’s) degree in life science, combined with four to five years’ experience in one or more clinical research roles such as CRC, senior CRA or QPPV (Qualified Professional in Pharmacovigilance).

Irrespective of where you are along this path, the remainder of this article charts a clinical research professional’s journey of growth in developing into a competent CRPM. For conceptual convenience, the process is discussed in two parts – Part 1 centers on the research and administrative skills needed for a CRPM, while Part 2 revolves around expertise in project management. The final sections address how the Advanced Clinical Research Project Manager Certification or ACRPMC facilitates the transition to a CRPM role.

The CRPM journey, Part 1: Research and administrative skills

By the time a clinical research professional is eligible to apply for a CRPM position, s/he has typically developed a range of competencies in the day-to-day running of clinical trials. In addition, a professional at this stage has usually acquired a good working knowledge of the planning and oversight required for a clinical research study.

In broad strokes, a CRPM candidate likely already has a knowledge base and skill sets in the following areas:

1. ICH-GCP guidelines, Title 21 of FDA CFR and IRB compliance

One of the first things every clinical research professional learns is the importance of adhering to the principles and policies of good clinical practice, as outlined in the ICH-GCP[3]—these guidelines set the framework for carrying out research in a manner that prioritizes the safety and welfare of human subjects and the quality and integrity of clinical data.

The ICH-GCP principles are mirrored by Title 21 within the US FDA’s Code of Federal Regulations (CFR)[4]. Clinical research across the US must conform to the requirements of Title 21. Part of Title 21 regulatory compliance requires nearly all clinical research studies to first be approved by an Institutional Review Board or IRB (also called an Ethics Committee). As clinical trials progress, any changes to the study trial protocol, consent procedures or data management system must likewise first be reviewed and approved by the IRB.

The CRPM has final responsibility for ensuring that all documentation necessary for clinical research regulatory compliance is maintained and updated as needed.

2. Clinical trial design concepts and parameters

A sound grasp of the clinical trials process is similarly a must for senior professionals in the team. Candidates for CRPM positions are thus expected to have a thorough understanding of key concepts and procedures relating to clinical research, including:

  • Phases 1 to 4 of clinical trials[5] 

  • Investigational products (IPs) including INDs and IDEs

  • Design concepts in clinical trials - control, randomization and blinding

  • Subject screening and selection, retention and study compliance

  • Trial data input, quality assurance, analyses and reporting

  • Adverse Event (AE) documentation and reporting

3. Pre-trial preparation

In some ways, the most crucial phase of a clinical trial is the preliminary or preparatory phase, during which all groundwork must be laid for the smooth and efficient conduct of the actual study. This phase must typically achieve the following objectives:

  1. Complete documentation for initiating clinical trials[6] – An IRB-approved clinical trial must have in place a host of documents covering important aspects of the study, including the investigator brochure (IB), trial master file (TMF), informed consent form, case report form (CRF), subject recruitment notice, laboratory protocol, study financial projections and so on.

  2. Identification and preparation of study site(s) – Most clinical research studies are run across multiple sites, which may be hospitals, clinics or other health-care facilities. Identifying suitable sites, establishing collaborative agreements with site administrators, as well as setting up the required infrastructure to carry out trials at each site is crucial in preparing for a clinical research study.

  3. Pre-trial publicity – The success of clinical trials depends on gathering large amounts of data from human subjects. Therefore, creating public awareness and interest right from the outset is critical to running clinical research studies effectively.

When setting up a study, the CRPM plays a central role in initiating and fulfilling each of the goals outlined above. Under the CRPM’s guidance, clinical research administrative staff including CRCs and CRAs work to put relevant documentation in place, prepare study sites and create public awareness about the study.

4. Active trial administration

The day-to-day running of an active clinical trial involves numerous administrative components, including:

  • hiring and training staff at clinical sites

  • tracking subject recruitment and retention

  • regulatory compliance in trial protocol, subject safety and data quality

  • Adverse Event (AE) documentation and reporting

  • oversight of trial drug storage and use

  • coordination among research teams across sites

  • tracking study finances

  • communication between study sponsors and clinical staff

  • electronic data capture (EDC) and management

  • timely renewal of necessary financial and regulatory approvals

These tasks are distributed among members of the investigative teams (PIs, co-PIs and other medical personnel) as well as administrative teams (CRAs, CRCs, QPPVs and other site staff). However, the CRPM is ultimately responsible for ensuring efficient administration that keeps the clinical trial on track.

5. Study termination procedures

Winding up a clinical trial similarly entails a number of administrative exercises. Here again, the CRPM must oversee execution, guiding team members in completing tasks on schedule and to the required standard:

  • site close-out (relieving staff, subject debriefing, equipment surrender)

  • final data consolidation and scrutiny

  • study completion documents for regulatory compliance

  • compilation of briefs and reports for regulatory authorities, study sponsors

The CRPM journey, Part 2: Expertise in project management[7]

Most aspirants to CRPM positions have usually been engaged in the clinical research process for at least a few years. Many have played administrative roles, working as CRCs, senior CRAs, QPPVs or site managers. In some cases, CRPM aspirants have clinical backgrounds, with expertise in drug research or medical monitoring.

Despite their hands-on experience with the clinical trials process, professionals wishing to transition to CRPM roles usually have limited exposure to the higher-level project management knowhow that is essential for an effective CRPM. This section provides a brief overview of the major project management domains relevant to clinical trial management:

1. Project and operations planning

A clinical trial is a major operation, involving a range of geographical and health-care settings, multi-disciplinary teams, as well as a complex array of regulatory and logistical requirements. Planning the stages, milestones and operations of a clinical trial is integral to assuring its success. Therefore, project and operations planning are the top priorities of a CRPM.

Some of the key elements involved in planning a clinical trial include:

  • Compiling a comprehensive study protocol describing the rationale, aims, design and methodology, data analysis plans, and trial procedure (/protocol)

  • Setting project goals, deliverables and milestones

  • Outlining a project personnel schematic that delineates team and sub-team structure and defines individual team member roles

  • Generating a responsibility blueprint with a clear break-up of tasks, targets and time-lines for each project goal and each team member

  •  Creating a communication plan that outlines the method and schedule for relaying information, updates and requests between and within teams

2. Financial forecasting and tracking

One of the biggest challenges confronting a CRPM is keeping the trial within budget, while making sure that resources are optimally allocated to cover all necessary project-related expenses. Clinical trials often suffer from scope creep, that is, the inclusion of additional goals and deliverables to those originally outlined, resulting in the project overshooting budget and time-line.

It is therefore recommended practice for a CRPM to work with study sponsors and senior team members in compiling a budget management plan at the very outset of the project. Such a plan not only specifies financial outlay for each of the goals and deliverables of the clinical trial, it also provides for periodic budget revisions to account for factors such as expanded project scope, rising costs and supply-chain changes.

3. Human resource allocation and oversight

The section on project and operations planning highlighted the importance of creating a personnel schematic as well as a responsibility blueprint at the start of a clinical trial. Through this process, a CRPM is able to clearly define roles for various team members in meeting project goals and milestones, and their contributions to each project deliverable.

However, in order to ensure collaborative effort and a cordial work environment, it is essential for a CRPM to also formulate a transparent hiring policy as well as disciplinary policy. These may be specific to the clinical trial or apply broadly across the CRO, or Clinical (/Contract) Research Organization. Well-documented policies facilitate the CRPM’s role in sourcing and motivating the best-fitted staff to play different roles in the clinical team.

4. Clinical data management and quality control

The data from a clinical trial are often its most valuable project outcome. As such, effectively managing the input, storage, analysis and quality control of study data is one of the foremost responsibilities of a CRPM.

Before beginning the active phase of the clinical trial, a CRPM coordinates with team members to put in place the following aspects of data management:

  • physical data storage system (files, binders, shelves, cabinets, etc.)

  • electronic data capture (EDC) and management system

  • physical and electronic data security systems

  • data input procedure

  • data cleaning and quality monitoring procedure

  • data sharing (import, export, access across clinical sites and teams)

  • data analysis and visualization procedure

  • periodic data review and reporting procedure

5. Risk management and mitigation

Owing to the high stakes nature of clinical research, running a clinical research study carries numerous risks. One of the major responsibilities of a CRPM is to develop a risk management plan to identify and circumvent potentially risky situations, and to mitigate consequences to the project in cases where an unforeseen risk impacts the trials process.

Some sources of risk in the management of a clinical trial include:

  • failure to obtain or document subject informed consent

  • errors in following trial protocol (timing, dosage, subject screening, etc.)

  • data security breach leading to compromised subject confidentiality

  • inadequate insurance coverage for potential adverse events of study

  • financial constraints arising from changes in study funding

  • limitations on study scope due to revisions in regulatory policy

Bridging the gap: Using ACRPMC to transition from clinical research professional to project manager

The foregoing section outlined how, despite their strong base in clinical research, CRPM aspirants generally lack the advanced knowhow and managerial skills required for leading a clinical research project. CCRPS’ Advanced Clinical Research Project Management Certification (ACRPMC) provides an excellent tool for bridging this gap and bringing candidates up to speed in all domains of clinical research management.

The table below offers a summary of the focus areas of the ACRPMC, detailing how each contributes to enhancing a candidate’s expertise and eligibility for the role of a Clinical Research Project Manager.

ACRPMC Focus Area

Contribution to CRPM Candidate Eligibility

ADVANCED REVIEW - I:

Regulatory compliance in clinical research

i.Fundamentals of subject (/patient) safety, ICH-GCP E6, Sections 2 - 4

ii.Regulatory compliance – FDA-CFR Title 21, Forms FDA 1571, 1572, 3454, 3455

iii.Investigational New Drug (IND) & New Drug Application (NDA), Investigational Device Exemption (IDE)

iv.IRB, Data Safety Monitoring Board (DSMB)[8]






ADVANCED REVIEW - II:

Clinical trial concepts

i.Process & phases of clinical testing (pre-clinical and phases 1 to 4)

ii.Importance of ‘control’ in testing[9], outcome validity, control methods (randomization, blinding)

iii.Subject (/patient) selection[10]: screening & exemption criteria, selection & retention, study compliance

iv.Clinical trial data management[11]: EDC, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Randomization & Trial Supply Management (RTSM)

v.Subject safety[12]: Risk assessment & Individual Case Safety Reports (ICSRs), Adverse Events (AEs), Adverse Drug Reactions (ADRs), Important Medical Events (IMEs)

ADVANCED REVIEW - III:

Pre-trial preparation

i.Documentation[13]: Regulatory binder, Investigator Brochure (IB), Trial Master File (TMF), Case Report Form (CRF), Delegation of Authority Log (DOAL), etc.

ii.Site preparation[14]: Site Selection Visits (SSVs), Site Qualification Visits (SQVs), site management agreements, investigator selection

iii.Pre-trial publicity: Advertisement for subject recruitment & retention






ADVANCED REVIEW - IV:

Active trial management & trial termination

i.Clinical trial protocol compliance, deviations & violations

i.Clinical site monitoring: subject safety, drug storage & safety, regulatory compliance

ii.Data monitoring: data security & access, Quality Management System (QMS), Quality Control (QC), Key Quality Indicators (KQI)

iii.Team monitoring: communication & collaboration, adherence to trial & safety protocols, research integrity & fraud

iv.Reviews & audits[15]: document & site audits, data audits, financial audits

v.Study termination: site close-out visits, data consolidation, subject debriefing

EXPERTISE BUILDING - I:

Clinical project management fundamentals

i.Project management basics[16]: key concepts, Project Management Body of Knowledge (PMBOK)

ii.Skills of a project manager: technical, administrative, human resources, public relations

iii.Clinical project stakeholders: sponsors, IRB, investigative & administrative staff, site administrators

EXPERTISE BUILDING - II:

Advanced clinical project management

i.Project planning & tracking, progress evaluation metrics

ii.Financial management[17]: project budgeting, site budgeting, advertising budget, payment tracking and management

iii.Risk management & problem solving[18]: problem solving managerial skills, identifying risks, avoiding failures, resolution of project problems (protocol deviations, compliance failures, project delays)

Fast-track to CRPM with the ACRPMC advantage

From the above summary table, it can be seen that the ACRPMC[19] program of CCRPS covers the entire spectrum of competencies required for managerial clinical research professionals. In addition to providing in-depth training in clinical project management concepts, tools and techniques, the program includes a review of foundational as well as advanced knowledge of the clinical trials process.

Aside from its comprehensive curriculum, certification through ACRPMC offers major benefits over conventional clinical research management courses, both online programs as well as those offered by colleges and universities. Some of the outstanding advantages of ACRPMC are:

1. Foundational review plus advanced training

The ACRPMC program stands apart from other online programs in its unique ability to launch as well as advance careers in clinical research. The program is equally effective at helping an aspiring graduate (BA in science or BS degree) to gain a competitive advantage in the clinical research job market, as it is at catapulting a senior clinical researcher into a managerial position. 

For CRPM aspirants in particular, the ACRPMC provides an unrivaled opportunity to brush up on the basics, in addition to acquiring valuable knowhow in clinical research project management, before embarking on the applications and interview process. 

2. Over 100 training modules (250 hours of coursework)

The course comprises over 100 modules. The advanced review focus areas address all aspects of the clinical research process, including important investigative concepts (trial design, randomization, subject screening, data analysis, etc.) as well as administrative processes (maintenance and updating of regulatory documents, case reports, trial logs, etc.). Additionally, the expertise building focus areas of the ACRPMC cover basic and advanced project management concepts and skills that equip candidates to tackle the challenges of leading a clinical research study.

3. ICH-GCP E6R2 compliant 

Designed by experienced Clinical Research Project Managers, the ACRPMC curriculum is fully compliant with the regulatory requirements of the ICH-GCP E6R2. The course coordinators additionally ensure that the content is regularly updated to reflect revisions to policy and new requirements.

4. Immediate enrollment and fast-tracked certification

Unlike college and university courses, trainees can enroll in the ACRPMC with just a few clicks. In addition, the self-paced course design allows students to skim through familiar topics, while giving more time and attention to new material. This is especially advantageous for working professionals and senior clinical research professionals wishing to refresh their knowledge. Trainees able to dedicate several hours per day to the program can complete the ACRPMC in as little as two weeks.

5. Multiple accreditations and industry-wide recognition

For ACRPMC-certified trainees, the solid credentials of the program confer a huge benefit when applying and interviewing for clinical research positions. Like other CCRPS courses, the ACRPMC is also accredited to ACCRE (Accreditation Council For Clinical Research and Education), ACCME (Accreditation Council for Continuing Medical Education) as well as ACPE (Accreditation Council for Pharmacy Education).

6. Clinical research résumé building and interview preparation 

The final modules of the ACRPMC help trainees in building their ability and confidence to face interviews for clinical research positions. Trainees completing the  comprehensive final examination not only have immediate access to a digital certificate, but are eligible to receive a letter of recommendation (LoR) that can strengthen their clinical research job application.

As the clinical research industry continues to grow at an unprecedented pace, there is rising demand for Clinical Research Project Managers who can blend their skill and  experience in clinical research with savvy, expert project management abilities. As a professional clinical researcher, the ACRPMC program offers you an unmatched opportunity to refresh existing knowhow and acquire new competencies, thereby leveraging your rise to the top echelons of management.

If you are a fresh graduate, the ACRPMC represents an unequaled, early-career edge in the clinical research arena. By equipping you with foundational as well as advanced knowledge and skills, ACRPMC certification does not merely improve your chances of securing an attractive clinical research position, it assures the rapid upward growth of your career graph.

Advanced Clinical Research Project Manager Certification (ACRPMC) program advantages.

References

  1. https://www.indeed.com/jobs?q=Clinical%20Trial%20Manager&l&vjk=311beece3c2d98b6

  2. https://www.payscale.com/research/US/Job=Clinical_Trial_Manager/Salary

  3. Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

  4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32

  5. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

  6. https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial

  7. Cullen H. 2016. Effective project management for clinical trials: A business approach. Ebook: https://www.imperialcrs.com/files/Project_Management_Ebook_Final.pdf

  8. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees

  9. Jüni P, Altman DG, Egger M. 2001. Assessing the quality of controlled clinical trials. BMJ. 323(42). DOI:10.1136/bmj.323.7303.42

  10. Farrell B, Kenyon, S, Shakur H. 2010. Managing clinical trials. Trials 11(78) DOI:10.1186/1745-6215-11-78

  11. von Itzstein MS, Hullings M, Mayo H, Beg MS, Williams EL, Gerber DE. 2021. Application of Information Technology to Clinical Trial Evaluation and Enrollment: A Review. JAMA Oncol. 7(10):1559–1566. DOI:10.1001/jamaoncol.2021.1165

  12. Yao B, Zhu L, Jiang Q, Xia HA. 2013. Safety Monitoring in Clinical Trials. Pharmaceutics. 5(1):94-106. DOI: 10.3390/pharmaceutics5010094

  13. https://files.nccih.nih.gov/s3fs-public/CR-Toolbox/Regulatory_Binder_Checklist_ver3_07-17-2015.docx

  14. https://www.appliedclinicaltrialsonline.com/view/selecting-study-appropriate-clinical-sites-3-steps

  15. https://www.clinicaltrialsarena.com/news/how-to-prepare-for-an-fda-site-inspection-5739632-2/

  16. PMBOK® Guide (7th ed.). 2022. Project Management Institute.

  17. Appleson M. 2015. The importance of budgeting in clinical trials and how a budget can prevent billing errors. Clin Invest. 5(5): 437-439. DOI: 0.4155/CLI.15.11

  18. Robinson M. 2005. Clinical trials risk management (1st ed.). CRC Press. DOI: 10.1201/9781420037654

  19. https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-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. 10,000,000
a. $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


$40,000
If 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 agreements
b. 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 Amendment
c. 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 institution
d. 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. 10,000,000
a. $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 contributions
a. 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 use
d. 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 administration
a. 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 expenses
a. 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 preparation
d. 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 agency
b. 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 investigator
a. 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 checks
c. 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 license
b. one copy of the official archives113.Formulation of the President's Budget;
Action by the Congress; Presentation (to Congress) and-Execution of enacted budget laws
What 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 housing
a. 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. 120
c. 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 years
d. 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 proposal
d. 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 body
a. 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 review
b. 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 embassy
a. 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 years
b. 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 Firearms
b. 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 contractor
a. 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. $75,000
d. $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 investigator
c. 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 committee
c. 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 Awards
d. 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 months
b. 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 continuation
b. 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 department
d. 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 only
a. 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 made
b. 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 expenditure
d. 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 Administration
a. 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-133
b. 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 contract
a. 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 entity
b. 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 grants
c. 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 grant
a. 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 system
d. 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 expenses
b. 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 narrative
d. 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 $25,000
b. 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 days
c. 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 Authority
a. 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 Foundation
d. 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 Animals
b. 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 confirm
b. 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 hospitals
c. 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 risks
b. 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 Regulations
a. 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 agency
c. 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 $25,000
b. 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 notice
d. 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 contract
d. 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 services
c. 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 costs
c. 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 diem
a. 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 agency
d. 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 inspection
a. 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 nonprofits
b. 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 Health
a. 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 Committee
c. 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 file
b. 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 positive
b. 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 animals
c. 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 Assistance
b. The Foundation Directory

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Clinical Trial Monitoring Reports and How to Write Them

Among the aspects in study is observation. Overseeing the advancement of any stage, measure, process, and procedure in real time is essential to the accurate conclusion of any clinical trial undertaking. Normal monitoring actions are needed to guarantee caliber , efficiency, compliance with predefined and regulations fundamentals, in addition to comprehensiveness, and precision within clinical investigation. Such actions also ensure that the trial isn't just conducted in compliance with Standard Operating Procedures (SOPs) however they also function to validate it is correctly reported and recorded. There is something with a part in the execution of trials. And this thing is known as trial development reports.

Such a report ought to be carefully prepared and it must summarize the means that a study is done. It also ought to point out recruiting progress and procedures; should emphasize and clarify adjustments to the analysis, and ought to point security issues if there are not some.

Aside from the ethics committee, researchers could also be necessary to present yearly improvement reports of an investigation (such as any applicable alterations or dangers ) to spouses, encouraging associations, and/or organizations, along with other interested parties if needed.

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In summary, tracking and reporting processes have an incredibly significant function in clinical trials. The right behaviour of these procedures not merely ensures compliance with legislation, regulations, and predetermined conditions, but in addition, it makes certain the study doesn't pose any dangers to their wellbeing. Progress reports, subsequently, empower practitioners, specialists, researchers, ethics committees, as well as others involved to keep a tab on the trial and its own advancement. They may signal any alterations or risks and may, therefore, react to them timely, correctly, and efficiently.

The objective of progress reports would be to accumulate and outline upgrades, key facets, along with summaries of a continuing trial. It's very crucial to be aware that progress reports must be filed to institutional evaluation board/independent integrity questionnaire (IRB/IEC), following a trial has obtained positive opinion.

One other important issue to mention is there are many different forms as soon as it comes to submitting progress reports that researchers must take into consideration before proceeding. Precisely, these kinds are:

Printing name and date of entry ought to be composed also. A digital copy is also needed to be delivered to the interested websites and committees inside a 30-day interval following the reporting procedure was completed.

The period of time whereby an advance report ought to be filed is at least one time in a year. Nevertheless, based upon the situation as well as the RECs' needs, these reports might be passed in more often, although the analysis is still going and till its official conclusion date.

Among the most important aspects of study is observation. Overseeing the advancement of any stage, measure, process, and procedure in real time is essential to the accurate conclusion of any clinical trial undertaking. Normal monitoring actions are needed to guarantee caliber, efficiency, compliance within predefined and regulations fundamentals. In addition, it guarantees comprehensiveness, and precision within clinical investigation. Such actions also ensure that the trial isn't just conducted in compliance with Standard Operating Procedures (SOPs). They must also function to validate it is correctly reported and recorded. There demands something vital as a part in the execution of trials. And this thing is known as trial development reports.

Such a report ought to be carefully prepared and it must summarize the means that a study is done. It also ought to point out recruiting progress and procedures; should emphasize and clarify adjustments to the analysis, and ought to point security issues.

Aside from the ethics committee, researchers could also need to present yearly improvement reports of an investigation (such as any applicable alterations or dangers) to spouses, encouraging associations, and/or organizations, along with other interested parties if needed.

If you're thinking about getting important skills on GCP or you also would like to upgrade your own know-how, subscribe to our comprehensive Good Clinical Practice class here.

In summary, tracking and reporting processes is an incredibly significant function in clinical trials. The right conduct of these procedures ensure compliance with legislation, regulations, and predetermined conditions. In addition, they make certain that the study doesn't pose any dangers to wellbeing. Progress reports, subsequently, empower practitioners, specialists, researchers, ethics committees, as well as others involved to keep a tab on the trial and its own advancement. Clinical professionals need to signal any alterations or risks to react to them timely, correctly, and efficiently.

The objective of progress reports would be to accumulate and outline upgrades, key facets, along with summaries of a continuing trial. It's very crucial to be aware that progress reports must be filed to institutional evaluation board/independent integrity questionnaire (IRB/IEC), following a trial that has obtained positive opinion.

One other important issue to mention is there are many different forms and when it comes to submitting progress reports that researchers must take into consideration before proceeding. Precisely, these kinds are:

  • Printing name and date of entry ought to be composed also. A digital copy is also needed to be delivered to the interested websites and committees inside a 30-day interval following the reporting procedure was completed.

  • The period of time whereby an advance report ought to be filed is at least one time in a year. Nevertheless, based upon the situation as well as the RECs' needs, these reports might be passed in more often, although the analysis is still going and till its official conclusion date.

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2018 Clinical Research Associate (CRA) Salaries Estimated from 1,850 American Employees

Skills Alliance Clinical Research Associate

Clinical Research Associate Job available

$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

$101,820 per year

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

$97,659 per year

Covance 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

$96,667 per year

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

$95,178 per year

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).

Clinical Research Associate Job available

$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).

Clinical Research Associate Job available

$76,150 per year

Novo Nordisk, Inc. 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

$95,242 per year

PPD 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

$91,293 per year

IQVIA 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

$89,615 per year

Cyberonics 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

$87,000 per year

AbbVie 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

$81,391 per year

ICON plc 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

$79,110 per year

PAREXEL 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

$81,281 per year

QuintilesIMS Clinical Research Associate

11 salaries

Clinical Research Associate Job available

$72,749 per year

MD Anderson Cancer Center Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$71,410 per year

Chiltern International Clinical Research Associate

5 salaries

$87,722 per year

Skills Alliance Clinical Research Associate

Clinical Research Associate Job available

$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

$101,820 per year

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

$97,659 per year

Covance 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

$96,667 per year

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

$95,178 per year

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).

Clinical Research Associate Job available

$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).

Clinical Research Associate Job available

$76,150 per year

Novo Nordisk, Inc. 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

$95,242 per year

PPD 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

$91,293 per year

IQVIA 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

$89,615 per year

Cyberonics 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

$87,000 per year

AbbVie 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

$81,391 per year

ICON plc 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

$79,110 per year

PAREXEL 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

$81,281 per year

QuintilesIMS Clinical Research Associate

11 salaries

Clinical Research Associate Job available

$72,749 per year

MD Anderson Cancer Center Clinical Research Associate

7 salaries

Clinical Research Associate Job available

$71,410 per year

Chiltern International Clinical Research Associate

5 salaries

$87,722 per year

Pharmanet Clinical Research Associate

5 salaries

$72,488 per year

Roche Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$71,586 per year

University of Florida Clinical Research Associate

11 salaries

Clinical Research Associate Job available

$69,492 per year

Department of Veterans Affairs Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$66,274 per year

Abbott Laboratories Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$66,095 per year

University of Utah Clinical Research Associate

19 salaries

Clinical Research Associate Job available

$66,775 per year

University of Minnesota Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$64,600 per year

University of Connecticut Health Center Clinical Research Associate

8 salaries

Clinical Research Associate Job available

$58,321 per year

St. Jude Children's Research Hospital Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$56,315 per year

Northwestern University Clinical Research Associate

6 salaries

Clinical Research Associate Job available

$54,342 per year

Duke Clinical Research Institute Clinical Research Associate

5 salaries

$73,447 per year

Emory University Clinical Research Associate

5 salaries

Clinical Research Associate Job available

$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

The Research Foundation for The State University of New York at Stony Brook Clinical Research Associate

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

5 salaries

$30.00 per hour

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How to Prepare for a Clinical Research Interview

Preparing for almost any interview may be a stressful experience. When interviewing for clinical research positions, interviews pose a special challenge which may require extra preparation. Below are the following five suggestions to be certain you are correctly prepared for a medical study project interview.

Do your research

First, take a deep dive into a company’s current information, discoveries or updates. LinkedIn is a superb source to observe factors about the business and its workers. Through LinkedIn it is possible to study how long employees work there, their credentials, and their own histories.

In addition, examine the business’ site, take notes and search for any current media releases. Based on your potential situation, your interviewer may would like you to share your own understanding of search practices and suitable protocol. Assessing these practices and describing them will help you through the meeting. For instance, if you're interviewing for a pharmaceutical medical study endeavor, you should take a look at the pharmaceutical sector and any appropriate research that's been published lately.

Get your resume into tiptop shape

The top two aspects clinical research partners look for in a candidate are your qualifications and resume. Your resume functions as your profile, and is also an extension of you. If your resume isn't up-to-date, then you might lose out on chances for possible interviews.

Be certain that you write your credentials into your resume and concentrate on the particular job which you are interviewing for. Examine the job description along with their needs for tips about what info you need to elaborate on, but don't over embellish you achievements.

Print multiple copies of your resume and then maintain them at a professional folder or notebook. Summarize your expertise and goals into a quick elevator pitch, and you’re ready for the next step.

Questions and ANSWERS

Before you go into an interview, it is critical that you prepare for questions the employer might ask. As a exercise, we recommend printing out the exact work description of the job positing and taking a look at every requirement. With every demand, write a vital illustration of how you've had a direct or related experience. Have precise and succinct examples of real life adventures that will assist you to swiftly collect your ideas throughout the interview. This exercise can help you to get accustomed to the position and realize areas where you're a solid candidate.

For a clinical study project interview, your previous clinical study experience is remarkably significant. Be certain you are extremely confident with all the comprehensive information of your previous clinical and research endeavors. Your interviewer may want to ask you certain questions, and you ought to be well equipped to answer. Most importantly, your interviewer will probably ask you about issues that you faced and how you worked together with the remaining part of the study team. Be conscious of occasions when you overcame hardship or faced an obstacle.

In addition answering to their questions, you need to come up with some of your own. This will help demonstrate your interest in the company and position. These questions ought to be unique and should reveal you have completed a thoughtful analysis on company. Make sure these questions are genuine and show a real interest in the employers. However, steer clear of questions regarding benefits, time bonuses and off. These questions can make you to look as though you believe that a provider owes you something, even though this is not the case.

Review your previous research

Walking into a meeting unprepared is essentially requesting collapse and also a missed job prospect. Interview preparation may be tiring and stressful, but the rewards are immense. Simply take the aforementioned five measures seriously, and you're on your path to a thriving clinical study project interview.

Prior to your clinical study job interview, put aside a couple of hours to gather your ideas. To begin, make sure you know who you are meeting . Locate them via LinkedIn and learn a little more about them. After that you can examine their own career path and create rapport more easily.

As mentioned above, along with your resume, be certain you are completely honest throughout this meeting. The job market can be challenging and you might be tempted to embellish a little, but we strongly urge you against that. During your interview, you could be caught in a lie, therefore entirely destroying your odds or, worse, you might get hired and then you're not able to complete the tasks you promised to be experienced in.

Lastly, get certified to make a strong candidate through CCRP Course.

At CCRPS.org, we offer seven courses and certification trainings to give you an advantage. 82% of our students are hired within the first month of taking the course. We are accredited by the Accreditation Council For Clinical Research & Education (ACCRE) and tailor our course to you. For example we offer special courses for nurses and an accelerated certification + internship opportunity for anyone with minimal or no clinical experience.  

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How to Improve My AMCAS Work & Activities

  • Below are five simple ways you can improve your AMCAS Work & Activities

    CCRPCOURSE.COM

    Educate where you can

    CCRPCOURSE.COM allows premeds in their gap year to be certified as Clinical Monitors to pursue a job where they have have expense-covered travel and oversee clinical trials run in medical schools around their region.

    Expand your system

    As a rigorous and open minded health care practitioner, you may be wondering exactly what you have to do in order to scale the corporate ladder quicker in the medical market. While the principle of'practice makes perfect' uses in the medical sector just like every other profession, progressing your health care profession will need more than your art in the business.

    Remember that as you expand and grow, the exact same occurs for your health care career. The five projects highlighted below are the very first couple of actions that will assist you to get a location you would like from the area of medicine. Practice them, along with your healthcare profession will expand also.

    Are your interests Dealing with your career route? Here is the very first question you need to have the ability to answer frankly in the event that you would like to improve your career in the health care market. Furthermore, if you're still not in the health care field, you need to ask yourself whether you may achieve the skills and instruction together with the experiences required to realize your objective. You might even elect for clinical research partner training for a means to improve your own comprehension.

    Make the most of the onsite courses in addition to any instruction opportunities being provided. Besides that, additionally, there are hospital control and Clinical Research online classes being supplied at some prestigious schools, including McMaster University and James Lind Institute. As previously stated, choosing a clinical research partner instruction is a wonderful method to raise your probability of progressing since the longer you improve, the further you're generating opportunities for your own.

    Stay ready, driven and motivated

    You always should stay concentrated on the job at hand and being ready for everything and anything that comes your way. It is a very good method of demonstrating that you just take your career seriously. Regardless of what the job you're accountable for, whether large or little, always be ready for it. Additionally, don't forget to get centered on your potential career goals too, even though it feels like the progress you would like is farther away than you originally envisioned. Maintain those friends that are interested in exactly precisely the exact identical field near. You are able to think about these as motivators who drive you to keep on chasing your dream.

    Picking a mentor has a few benefits, that will, in turn, assist you in improving your health care career. If you locate a suitable individual that's eager to take you under their wing, then begin with taking a good look at the job ethics and degree of knowledge. This will definitely point you in the ideal way, as you'll be asking yourself how you are able to be like these. Second, your mentor might assist you to network with other seasoned professionals who he/she understands.

    Your present or former teacher from medical college will even share his wisdom and adventures with you. This may be a fantastic place to look for out information on whatever that you would like to learn regarding your health career. Utilizing the adventures of your mentor or boss since your aims may be the simplest route to follow if you would like to advance professionally.

    Re-evaluate your livelihood

    Another great approach to progress your career is by simply linking with likeminded people who work as caregivers. These professionals are available literally anywhere -- the establishment you've have your health care degree from, in your current (and past ) job, in seminars and conventions, in LinkedIn classes, etc.. ) If you would like to branch out farther than the men and women in your institution, you can attempt using online social networks to associate with more people just like you. Conventional social networks like working on your area and associations also work miracles.

Applying to medical school can be difficult, but it can also be one of the most important decisions of your life. The AMCAS is the American medical school application system that all students use. A rich, well put together application can help you get into your dream school. Below are four simple ways you can improve your AMCAS Work & Activities

Expand your system

As an aspiring health care practitioner, you may be wondering exactly what you have to do in order to scale the corporate ladder. While improving your skills and practice helps your career in the medical sector as well as every other profession, progressing your health care profession will need more than perfect bedside manners.

Remember that as you expand and grow, the exact same occurs for your health care career. The five questions highlighted below are the guide to the first actions that will assist you to get a location you would like from the area of medicine. Practice them, along with your healthcare profession will expand also.

Are your interests Dealing with your career route? Here is the very first question you need to have the ability to answer frankly in the event that you would like to improve your career in the health care market. Furthermore, if you're still not in the health care field, you need to ask yourself whether you may achieve the skills and instruction together with the experiences required to realize your objective. You might even elect for clinical research partner training for a means to improve your own comprehension.

Make the most of the onsite courses in addition to any instruction opportunities being provided. Besides that, additionally, there are hospital control and Clinical Research online classes being supplied at some prestigious schools, including McMaster University and James Lind Institute. As previously stated, choosing a clinical research partner instruction is a wonderful method to raise your probability of progressing since the longer you improve, the further you're generating opportunities for your own.

Stay ready, driven and motivated

You always should stay concentrated on the job at hand and being ready for everything and anything that comes your way. It is a very good method of demonstrating that you just take your career seriously. Regardless of what the job you're accountable for, whether large or little, always be ready for it. Additionally, don't forget to get centered on your potential career goals too, even though it feels like the progress you would like is farther away than you originally envisioned. Maintain those friends that are interested in exactly precisely the exact identical field near. You are able to think about these as motivators who drive you to keep on chasing your dream.

Picking a mentor has a few benefits, that will, in turn, assist you in improving your health care career. If you locate a suitable individual that's eager to take you under their wing, then begin with taking a good look at the job ethics and degree of knowledge. This will definitely point you in the ideal way, as you'll be asking yourself how you are able to be like these. Second, your mentor might assist you to network with other seasoned professionals who he/she understands.

Your present or former teacher from medical college will even share his wisdom and adventures with you. This may be a fantastic place to look for out information on whatever that you would like to learn regarding your health career. Utilizing the adventures of your mentor or boss since your aims may be the simplest route to follow if you would like to advance professionally.

Re-evaluate your livelihood

Another great approach to progress your career is by simply linking with likeminded people who work as caregivers. These professionals are available literally anywhere -- the establishment you've have your health care degree from, in your current (and past ) job, in seminars and conventions, in LinkedIn classes, etc.. ) If you would like to branch out farther than the men and women in your institution, you can attempt using online social networks to associate with more people just like you. Conventional social networks like working on your area and associations also work miracles.

Take courses from CCRPS and learn more on how to become a clinical research professional.

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CCRPS Clinical Research Certificate Program Overview

This program enables you to master practical aspects of clinical trial conduct and management. For more info read our blog.

The First Step to Clinical Research Certificate Program

_________________________________________________________________________________

CCRP CRRA Certified Clinical Researcher Associate

This program requires only a medical sciences education background such as FMGs, BSNs, and Bachelors graduates. Clinical Research Associate Training Course is a 110 module course led by Senior CRA and Physician of 25 Years, Dr.Kamal. This course provides the training, experience, interviewing, letter of references, and connections you need to get a job supervising clinical research efforts. We offer clinical research associate training and placement for nurses, science bachelor graduates, and international medical graduates.

_________________________________________________________________________________

SCDM CCDM Certified Clinical Data Manager

Eligibility Requirements

APPLICANTS FOR THE CERTIFIED CLINICAL DATA MANAGER (CCDM™) PROGRAM MUST MEET ONE OF THE FOLLOWING CRITERIA

  • Bachelor’s degree or higher and minimum two years full-time CDM experience

  • Associate’s degree and minimum three years full-time CDM experience

  • Four or more years full-time CDM experience

  • Part-time work experience equal to or surpassing full-time equivalent in criteria above

ACRP CCRA Certified Clinical Research Associate

The CCRA® eligibility criteria define the minimum experience required before a CRA can apply for the program. It is important to compare the CRA eligibility criteria with your career and educational experiences to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.

CRA Certification Eligibility Requirements

In order to be deemed eligible to take the CCRA® exam, applicants for the CCRA® credential must be able to provide evidence through a job description, detailed CV, or other documentation that they:

  • Work independently of the investigative staff conducting the research at the site or institution. This means they do not report to the PI or site manager and that they do not have the ability to change or manipulate data, and;

  • Work on behalf of the sponsor. This means that they are contracted by the “sponsor” to perform an independent monitoring function. The “sponsor” can be a pharmaceutical or device company, a granting agency, a university department, a physician, etc., and;

  • Perform all of the CCRA® essential duties as detailed below for a required minimum number of hours. Hours performing the CRA essential duties can include hoursdocumented up to the date of the exam and/or through previous employment. The required number of hours is dependent upon one’s educational background.

The CRA Certification Handbook has complete information on eligibility requirements.

ACRP CCRC Certified Clinical Research Coordinator

CRC Certification Eligibility Requirements

In order to be deemed Eligible to take the CCRC® exam, applicants for the CCRC® credential must be able to provide evidence through a job description, detailed CV or other documentation that they:

  • Perform all of the CRC essential duties as detailed below for a required minimum number of hours.

  • Hours performing the CRC essential duties can include hours documented up to the date of the exam and/or through previous employment. The required number of hours is dependent upon one’s educational background.

SoCRA CCRP Certified Clinical Research Professional

The applicant must be working with Good Clinical Practice (GCP) guidelines under IRB/IEC/REB-approved (or specifically exempted) protocols.

The applicant must meet one of the following Eligibility Criteria noted below.   Please note that most candidates will be eligible under Category 1. 

For purposes of eligibility, please view SOCRA's definition of a Clinical Research Professional.

If you have a question about Candidate Eligibility please email SOCRA at certification@socra.org

Category 1

Applicant must have (and be able to document) ALL of the following qualifications:

Please note:  If you have completed two (2) years of full-time employment as a clinical research professional in the past five years, you will NOT need to provide supporting documentation for your educational experience.

Category 2

Applicant must have (and be able to document) ALL of the following qualifications:

  • Hold a degree in "Clinical Research" from an Associate, Undergraduate, or Graduate Degree Program AND 

  • Have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional

Category 3

Applicant must have (and be able to document) ALL of the following qualifications:

  • Hold an Undergraduate or Graduate Certificate in “Clinical Research” with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND

  • Hold an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND 

  • Have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional.

ACRP CCTI Certified ClinicPrincipal Investigator

The CPI® eligibility criteria define the minimum experience required before a PI can apply for the program. It is important to compare the CPI® eligibility criteria with your experience to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.

PI Certification Eligibility Requirements

In order to be deemed eligible to take the CPI® exam, applicants for the CPI® credential must be able to provide evidence through a job description, detailed CV or other documentation that they:

  • Have a doctorate level degree and;

  • Have proof of employment as a PI during at least two (2) of the most recent five (5) years and;

  • Perform all of the essential duties as detailed below.

The PI Certification Handbook has complete employment definitions.

Update: The CPI Exam is the first exam being offered to all investigators with a doctoral-level degree. A license to practice medicine is no longer required.

NAIM CIM Certified IRB Manager

To qualify for the Certified IRB Manager Examination, you must meet the following
requirements:
     • Applicants must have a Bachelor’s Degree and 2 years of relevant IRB
      Management experience within the last 5 years.
      OR
     • An Associates Degree from a two year college or technical school and 2 years
      of relevant IRB Management experience within the last 5 years.

CCIP CIP Certified IRB Professional

Eligibility Requirements

This certification program is for individuals whose primary job responsibilities include substantial participation in overseeing, administering or performing the daily activities of an IRB as part of a HRPP. Individuals involved in IRB activities who meet the following eligibility requirements are eligible to take the examination: 

  • A Bachelor's degree plus two years of relevant HRPP experience, completed on or before the first day of your chosen testing period (see front cover)

or

  • Three years of relevant HRPP experience, completed on or before the first day of your chosen testing period

or

  • Current certification as a CIP

RACC CRA Certified Research Administrator

Bachelor’s Degree and three (3) years of professional experience in research or sponsored programs administration either in a sponsoring or recipient organization or the equivalent in a self-funded organization;

OR

An Associate’s Degree and five (5) years of professional experience in research or sponsored programs administration either in a sponsoring or recipient organization or the equivalent in a self-funded organization;

OR

No degree and six (6) years of professional experience in research or sponsored programs administration either in a sponsoring or recipient organization or the equivalent in a self-funded organization. *

MAGI CRCP Certified Research Contract Professional

People often ask how to prepare for the exam. Two years of experience with a variety of negotiation partners may be sufficient to pass the exam. A careful reading of MAGI's Model CTA, Clinical Trial Agreement Handbook (Original), and Model CDA is helpful. There are numerous relevant articles in the Journal of Clinical Research Best Practices. Attending MAGI's Clinical Research Conference is good preparation, provided you attend sessions and workshops that address relevant topics where you need more knowledge. Sample questions, study guides, or other study materials are not available. However, imagine an exam for professional chefs. One question might be, "Describe the process of making an omelette." Another might be, "List five spices used in Chinese cuisine." Another might be, "What are the pros and cons of gas vs. electric stoves?"

RAPS RAC Regulatory Affairs Certification

The RAC is the only credential for regulatory professionals in the healthcare product sector. The RAC demonstrates to employers, clients and colleagues essential knowledge, critical thinking abilities and a commitment to continuing professional development. It is designed for working regulatory professionals, with at least three to five years of regulatory experience. There are six different RAC exams. The US, EU and Canada exams test regional regulations and involvement with regulatory bodies. The global exam focuses on international standards and guidelines. The devices and drugs exams have a global focus yet aligns to a specific sector of regulation knowledge. All six exams test for regulatory knowledge, critical thinking and analysis throughout the lifecycle of a product.

SQA RQAP Registered Quality Assurance Professional

The Society of Quality Assurance is proud to offer the professional credential Registered Quality Assurance Professional (RQAP) for professionals working in Good Laboratory Practices as well as for professionals working in Good Clinical Practices. Registration is a recognized standard of experience and knowledge throughout the QA industry, in the US and around the world.

What the credential demonstrates

  • Proof of your knowledge of the regulations/guidelines and how they are applied

  • Commitment to a high quality standard in the QA industry

  • Personal professional growth and achievement

How it Works

  1. Professionals must pass an examination in either Good Laboratory Practices or Good Clinical Practices to receive the RQAP credential.

  2. Registered professionals must re-register every three years by submitting documentation of ongoing professional activities. These activities include, but are not limited to:

More on RQAP Re-registration

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CRA, Students AD CRA, Students AD

From The Course Creator: CRA Clinical Research Certification & Training

CRAs can expect to make between $75-90k/year within their first year. CRAs who are physicians from foreign countries are considered MDs in this position. CRAs who are nurses which transitioned are treated remarkably well among the hospitals they visit or monitor. As a supervisor of clinical trials, this also paves ways to enter higher-level administrative and leadership roles in medical centers, institutions, and pharmaceutical companies.

Clinical research associates are currently the highest paid upper-level medical professionals in the pharmaceutical and medical industry, second only to physicians. Many remote and traveling (expenses-covered) jobs are available for CRA positions for those who have a background or certification training. 

The obvious difficulty in searching for these positions is getting selected and interviewed without experience. CCRP Course works directly with:

  • International Medical Graduates (MBBS, FMG, IMGs)

  • MDs without residence

  • Bachelor’s of science or healthcare-related fields

  • Bachelor’s of nursing and nurses

  • Master’s of science graduates

CCRPS’ courses strives for you to achieve the knowledge, certification, and resume experience needed to be selected and hired by pharmaceutical companies.

CRAs can expect to make between $75-90k/year within their first year. CRAs who are physicians from foreign countries are considered MDs in this position. CRAs who are transitioned nurses are treated remarkably well among the hospitals they visit or monitor.

As a supervisor of clinical trials, this position also paves ways to enter higher-level administrative and leadership roles in medical centers, institutions, and pharmaceutical companies.

Courses for Quality CRA Training                   Modules per Course      

1. ICH GCP Training                                                     15                                              

2. Quality Monitoring                                                     45                                           

3. Regulatory Training                                                   15                                            

4. Audit and Inspections                                                 6                                           

5. Writing Professional Monitoring Reports                    16    
-Developing Follow Up Reports                                         

6. Subject Recruitment Retention and Compliance         5                   

7. Misconduct and Fraud                                                2                     

8. Competency Testing of CRA’s                                     6               

                                                                                     …………                                                                                        Total         110 Modules 

 

Training certification will be provided at the end of the course. This can be listed on your resume as an educational experience as well as a volunteer experience for the amount of time it takes you to complete the course.

The tuition fee is $1,795 ($18 per module) is offered over a 4-month payment plan in this link

The online training can be completed within 1-4 months time and can start within 24 hours of tuition payment.

After module completion we begin your recruiter-interaction training by providing the following: 

1.   Interview Prep (3 interview rounds training) 

2.   Resume experience of training 

3.   Recruiter based references 

4.   Multiple employee references

5.  LOR’s  

Having been a Senior CRA for 15 years, my job is to ensure that entering and succeeding this field is easier for our students. If you are interested in this field, below are some CRA articles you may find useful.

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