(CRC)
Clinical Research Coordinator Certification
Guide To Becoming A Clinical Research Coordinator
What is a Clinical Research Coordinator
Clinical research coordinators play a crucial role in administering clinical trials, overseeing various aspects such as data collection, participant engagement, and adherence to trial standards. As of 2024, their responsibilities have expanded to include ensuring smooth trial operations and effective communication with subjects. Here's a revised version of your content:
Clinical research coordinators are pivotal in the administration of clinical trials. Their primary responsibilities typically involve administering questionnaires, informing participants about study objectives, collecting data, and managing all trial procedures. In 2024, their roles have evolved to encompass strict adherence to established trial standards and active involvement in participant recruitment.
Effective engagement with subjects is paramount for clinical research coordinators, necessitating strong communicative and interpersonal skills.
Responsibilities
Clinical research coordinators shoulder a multitude of responsibilities, all critical to the success of their endeavors:
Maintaining meticulous records of all studies in compliance with guidelines.
Adhering rigorously to ethical standards governing research.
Ensuring compliance with regulatory standards.
Administering questionnaires and other study protocols.
Managing the research budget efficiently.
Overseeing the smooth execution of trials.
Engaging with participants to address concerns and gather insights.
Ensuring functionality and availability of necessary equipment and supplies.
Participating actively in participant recruitment efforts.
Collaborating with laboratories to share findings.
Requirements
Qualifications for clinical research coordinators vary depending on location and employer. However, common requirements as of 2024 include:
An associate nursing degree or related field.
A minimum of two years' experience in the healthcare industry.
An analytical mindset and keen attention to detail.
Exceptional interpersonal skills for effective participant engagement.
Willingness to pursue continuous learning opportunities independently.
Strong organizational abilities.
Excellent verbal and written communication skills.
In a dynamic field like clinical research, staying abreast of advancements and regulations is essential for success.
This revision integrates the existing content with updates reflecting the current landscape in 2024, emphasizing the evolving nature of clinical research coordination.
Roles And Duties Of Clinical Trial Coordinator
In 2024, the part of a clinical investigate facilitator includes overseeing clinical inquire about at investigate destinations in understanding with convention, ICH-GCP rules, and other administrative necessities. Understanding the errands of a clinical investigate facilitator requires understanding into the timeline of a inquire about location, which regularly unfurls in three stages:
Some time recently Beginning the Clinical Trial:
During this arrange, consider organizers assemble and total surveys from supports and different Contract Inquire about Organizations (CROs). Clinical inquire about facilitators at that point collect information from the foremost examiner and transfer it back to partners. Supports select areas based on achievability survey reactions and conduct pre-site evaluation visits to finalize taking an interest sites.
Sites conducting investigate must hold clinical trial facilitator certification to continue with agent gatherings, regularly held at universal or national levels. Some time recently commencing the trial, clinical inquire about facilitators are possessed with submitting different reports to the morals committee, counting subject journals, investigators' CVs, clinical investigate assentions, convention signature pages, certification, indemnification letters, protections certificates, clear Case Report Shapes (CRFs), and ponder logs.
Conduct Amid the Clinical Trial:
Clinical investigate facilitators must have a exhaustive understanding of the think about convention, counting avoidance and consideration criteria. They get educated assent from subjects, as spoken to by Central Examiners, and collect pre-medical records. Facilitators oversee planned visits agreeing to the examination convention, guaranteeing compliance with prohibition and consideration criteria some time recently selecting qualified subjects. Taking after each visit, facilitators compile information into case reports, keeping up overhauled records all through the trial.
Coordinators are capable for overseeing ponder medicate responsibility, utilizing Intelligently Web Reaction Frameworks (IWRS) and Intuitively Voice Reaction Frameworks (IVRS) to record subject visits. Legitimate capacity and dealing with of investigational items, counting temperature observing, are pivotal. Facilitators too collect essential information on unfavorable occasions, observing lab reports and securing Vital Agent signatures.
After Completing the Clinical Trial:
Upon trial completion, facilitators audit and upgrade all reports some time recently closure, guaranteeing precision and completeness. Clinical Inquire about Partners (CRAs) confirm materials on the trial's last day. Facilitators help in chronicling records at the location, keeping up records for 15-20 years.
In outline, clinical investigate facilitators play a essential part in managing clinical trials at the location level, serving as a crucial connect between morals committees, examiner destinations, and supports. Their fastidious administration guarantees compliance, information judgment, and the fruitful execution of clinical investigate endeavors.
Education Requirements Of A Clinical Research Coordinator
To set out on the travel of getting to be a Clinical Investigate Facilitator in 2024, one must take after a organized way. Here are the steps you require to take:
Step 1: Tall School Graduation
Completion of tall school lays the establishment for your scholastic travel. Center on subjects like material science, chemistry, science, arithmetic, measurements, and communication to construct a solid base for your future studies.
Step 2: Bachelor's Degree
Seek out colleges and colleges advertising bachelor's degrees in wellbeing sciences. These programs prepare understudies with the vital devices and techniques for research facility work, definition of solutions, and conducting clinical trials and thinks about. Whether through on-campus or online courses, guarantee the educational programs covers both authoritative and logical angles basic for a clinical investigate coordinator.
Step 3: Work Experience
Gain down to earth encounter by volunteering at clinical trials and securing entry-level positions in teach or investigate research facilities. Investing a year or two in this capacity will give profitable hands-on encounter pivotal for certification and employment.
Step 4: Online Graduate Certificate
Consider seeking after an online graduate certificate in clinical investigate organization. These programs regularly span 18 credit hours, displaying devotion and improving your career prospects. Courses center on administrative and communication aptitudes, inquire about plan, location administration, information administration, measurements, member security contemplations, and more. These credits can regularly be exchanged to a master's program in the same institution.
Step 5: Master's Degree (Online or On-site)
Advance your information and career prospects by getting a master's degree, either online or through conventional on-site courses. Master's programs dive more profound into essential administrative issues and clinical inquire about checking, giving comprehensive planning for certification.
Step 6: Get Certification
To hone as a certified Clinical Inquire about Facilitator, you must pass an exam and get certification. Organizations like CCRPS offer globally recognized certification programs. Upon certification, you'll be well-equipped to set out on a satisfying career in clinical inquire about coordination.
By perseveringly taking after these steps, trying people can clear the way towards getting to be capable Clinical Inquire about Facilitators in the energetic field of restorative inquire about.
Salary Of A Clinical Research Coordinator
Salary of a Clinical Research Coordinator
How Much is a Clinical Research Coordinator’s Salary?
As of Walk 5, 2024, the normal yearly pay for a Inquire about Facilitator in the Joined together States is $80,570. This deciphers to around $38.74 an hour, $1,549 per week, or $6,714 per month.
While pay rates for Investigate Facilitators can shift essentially, with a few gaining as much as $112,500 yearly and others as moo as $21,500, the larger part drop inside the extend of $61,000 (25th percentile) to $99,500 (75th percentile). Beat workers, speaking to the 90th percentile, can make up to $110,000 per year.
The impressive variety in compensations, up to $38,500, recommends various openings for progression and expanded pay based on components such as expertise level, area, and a long time of experience.
Based on later work posting action, the Investigate Facilitator work advertise in the Joined together States is not especially dynamic. Be that as it may, certain cities offer higher-than-average pay rates for Inquire about Facilitators. Among the beat 10 most noteworthy paying cities are Berkeley, CA; Modern York City, NY; and Renton, WA. These cities offer normal pay rates surpassing the national normal, with Berkeley, CA, driving with an normal compensation surpassing $97,543.
While migrating to these cities may show openings for financial progression, it's basic to consider components such as the fetched of living and the generally little variety in normal compensations among the best cities. This recommends restricted potential for critical wage increments based exclusively on area.
Free Online Clinical Research Coordinator Training
Free courses for CRC training are available is specific subjects
You can search for free courses on the following subjects to get training that a CRC may benefit from:
Medical Ethics Course: - In this course, the professors introduce important values, which include autonomy, non-maleficence, dignity, justice, and honesty. The students consider how to develop a framework for creating ethical decisions that were informed by laws and values. You will discuss ethical issues, like favorable cost-benefit ratio, participant selection, and confidentiality. It is one of the best clinical research coordinator certifications online courses to help you to crack the exams.
Clinical Research Principles Course: - This clinical research coordinator certifications online course will provide an overview of the process of clinical research, development, and the history of it. Here the students can quickly learn the management skill, which includes the practice guidelines of clinics. You will also learn about the roles of research team members and development phases of the clinical trials.
Medical Terminology Course: - This clinical research coordinator certification online courses cover up the standard medical terminology which uses up in the clinical research field. This knowledge will help enhance your effectiveness at managing the data and quality control.
Health Information And The Law Course: - In this clinical research coordinator certifications online course, the students need to understand the overview of guidelines and the regulations which protect the human subjects and ensures research integrity. T You will learn about the obligations of the regulatory bodies. Here, students will even discuss the types of violations constituted by scientific misconduct and consider their consequences.
Introduction To The Health Records Courses: - This clinical research coordinator certifications online explore the confidentially and its purpose. This course will consist of how to use medical records for planning, the caring of the patient, and how to use laws for these records.
Study Of Financing Course: - This clinical research coordinator certifications online will provide you an overview of funding management of the study. Here students get to learn how to submit the proposals and how to create them. This course compiles the financial regulations, which consider the indirect and the direct cost.
Medical Device History: - In this clinical research coordinator certifications online course, it will provide you to explore the current trends which are affecting the research, which also explores the history of devices in medical. Students will be provided with a lot of case studies that can be considered from a business, medical, ethical, and also legal perspective.
These are a few free clinical research coordinator certifications online courses that you can go for preparing for your clinical research certifications. These courses can help you a lot in every perspective of exams, but the best option is to take a course that can provide you with in-depth accredited training. Overall, getting accredited certification from a trusted body such as CCRPS is the best option in showing employers your competency for coordinator roles.
CRC Course Syllabus
Introduction to CRC
Accreditation Council For Clinical Research & Education for CCRPS
Duties and Responsibilities of Clinical Research Coordinators
Employment Advancement for Clinical Research Coordinators
Process Map of A Sponsored Clinical Trial Study
Orientation Manual for Clinical Research Coordinator
Protocols and Guidelines
SOPs and MOPs
SOP Template
MOP Outline
MOP Example
Clinical Research Coordinator Toolkit
Routine Site Visit Report
Adverse Event Tracking Log
Chart Audit Tool
Regulatory File Review Tool
Monitoring Log
ICH GCP
An Introduction to Clinical Research
An Overview of ICH GCP
Code of Federal Regulations
CFR 21 Part 11
Sponsor/CRO Responsibilities
ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles
Reporting Responsibilities of the Investigators
Ethics of Research Involving Children
Ethics of Research Involving Pregnant Women and Fetuses
Ethics of Research Involving Prisoners
ICH GCP E6 and E2A - Adverse Events
ICH GCP 5.5 Trial Management – Data Handling and Record Retention
a) Common Terminology Used In Clinical Research
b) Commonly Used Abbreviations and Terms in Clinical Research
ICH GCP Quiz
Advanced Clinical Trials Foundations
Designs of Clinical Trials
Stakeholders in Clinical Research and Their Relationships
Site and Investigator Selection
Site Initiation Visit (SIV)
Site Qualification Visit
Routine Monitoring Visit
Site Close Out Visit
Source Documents and Informed Consent Forms
Quality Monitoring Quiz Modules 1-15
Inclusion Exclusion Criteria in Clinical Research
Interactive Voice Response System - IVRS
Protocol Deviations and Violations
Institutional Review Board
Quality Control in Clinical Research
Blinding in Clinical Trials
Communication between Blinded and Unblinded Staff
Investigational Product Accountability in Clinical Trials
Quality Monitoring Quiz
Adverse Drug Reactions
Basics of Adverse Event Monitoring
Adverse Event Reporting
Safety Reporting Requirements for Sponsor Investigators of An IND
IND and NDA Process
Do’s and Don’ts of a Case Report Form Design
Compliance and Regulations
Regulatory Documents in Clinical Research
Regulatory Affairs
Essential Regulatory Documents Guidance and Binder Tabs (Part 1)
Essential Regulatory Documents Guidance and Binder Tabs (Part 2)
Financial Disclosure- Duties and Strategies for Clinical Studies
Financial Disclosures and Conflicts of Interest in Clinical Research
FDA Form 1572 - Part 2
Delegation of Authority Log – DOAL
Investigators Brochures
Protocol Continuing
IND Application
Trial Master File Reference Guide
Regulatory Training Quiz (20 Questions)
Audit and Inspections
FDA Warning Letter
Site FDA Audit Inspection Checklist
How to Survive Through an FDA Inspection
Do and Don’ts during an FDA Inspection
Audits and Inspection Quiz
Subject Recruitment and Retention
Compliance Requirements in Clinical Trials
Subject Recruitment and Retention (Part 2)
Increasing Subject Compliance in Clinical Trials
Ethical Consideration Associated with Investigator Payment and Patient Recruitment
Advertisement Aid in Subject Recruitment and Retention
Misconduct and Fraud
Misconduct in Research – Detecting Falsification
Statistics and Data Management of Clinical Trials
Data Management In Clinical Research
Good Clinical Data Management Protocol
Financial Management of Clinical Trials
Financial Management Fundamentals
Developing A Trial Budget
Budget Worksheet
Final Examination
Competency Exam (52 Questions)
Are you looking for a comprehensive and reliable training program for clinical research coordinator certification?
CCRPS Clinical Research Coordinator Training provides the most advanced, yet easy-to-follow coverage of GCP guidelines. Our program exceeds expectations with checklists, images, and examples that help students apply concepts learned. Upon completion of our program, students are able to pass certification exams with flying colors and are trusted by employers all over the world. Make the smart choice and choose CCRPS for CRC training.
7 Reasons Why You Should Start a Career in Clinical Research
begin a Career in Clinical Research
How you ever thought that there’s a perfect job out there for you, but you just haven’t found it yet? If you are motivated, informed, and interested in a science and medical career, you might have just found your answer. Many clinical research professionals say this is the golden ticket to a great career in the science field.
Why Clinical Research as a Career
The clinical research industry is a highly lucrative and expanding field. The global clinical trials market has been estimated at $46.8 billion in 2019.
As the push for new vaccines and therapeutics continues to get stronger, the field is expected to grow even more in value. Experts predict that the global market will hit $69.9 billion by 2027. The future in clinical research is bright, and it is one that you will want to be a part of.
Contrary to popular belief, working in clinical research doesn’t have to mean you have to stay in a lab. There are demands and opportunities for every skill set, if you know how to find them. Below, I have put together an in-depth guide on why you should get into clinical research.
Working in Clinical Research
You like a job that’s flexible
Don’t like working in a cubical? How about heading to the airport every morning instead? If you like a job that keeps you moving, then becoming a Clinical Research Associate (CRA) and working in clinical trials might be the right move for you. Learn more about becoming a CRA with this CRA Certification Course.
CRAs, contrary to what most people believe, don’t collect data or interact with patients. A CRA’s day-to-day job is to travel between different research sites and verify data transcription (i.e., data management). CRAs can also become part of the project management as a clinical trial manager of an entire trial.
They are also called “monitors” and a part of "regulatory affairs", because it is also their job and clinical experience to ensure that every site is following proper compliance and protocols.
There are two types of CRAs: home base or in-house. Home base CRAs work remotely. That means they work and travel from home. Most CRAs work for contract research organizations who are hired by sponsors to conduct their multi-site trials.
If you get tired of working home base, you can become an in-house CRA. In-house CRAs stay in one site and work together with a home base CRA to keep each other updated with what is happening at their site.
You like working with people
Have you ever been told that you are a people person with great communication skills? If talking to someone about how you can change their health for the better sounds like something you’d enjoy, you should definitely look into becoming a Clinical Research Coordinator (CRC). Explore our Clinical Research Coordinator Course to get started.
CRCs are the backbones to every project. They conduct patient visits, input source documents into the electronic data capture (EDC), and ensure that every trial is following compliance. They are also responsible for handling regulatory documents and updating the Principal Investigator (PI) with trial results.
CRCs conduct a variety of tasks, all of which impact the progress and development of the trial. Every successful clinical trials team needs is a good CRC. So, if you have strong interpersonal skills and know how to stay organized, you will be an indispensable part of the team.
You are detail-oriented and tech-savvy
Are you a self-proclaimed techie? Perhaps you’ve dabbled in coding, pick up computer programs easily, and maybe even have a background in IT. Technology is the future. If you think you have a knack for organizing data, you should look into becoming a Clinical Trial Assistant (CTA). Check out our Clinical Trials Assistant Training to learn more.
CTAs, also known as Clinical Research Assistants, manage the Trial Master File (TMF). They file, archive, and maintain trial documents and study files. They are also responsible for closing inquiries from the CRA, as well as providing administrative support to the research team. Every important step in clinical research, pre-clinical research, study startup, site management, needs a dependable CTA.
While most jobs in clinical research require some understanding of technology, it is especially important for the CTA to know what they are doing when it comes to managing trial documents and study files. In addition, it is equally important that the CTA is organized and knows how to pay attention to detail.
Working in Clinical Trials
Means you like a good salary...with room for promotion
Though there are many career paths within clinical research, most people begin their career as CTAs or CRCs in entry-level positions. Depending on your skill set and what kind of experiences you can bring to the table, either position will help you get your feet through the door.
According to salary.com, a CTA’s average salary in 2020 is $63,000. They generally earn between a range of $54,300 and $73,000, and are provided with benefits such as healthcare and social security.
If being more hands-on in the research process appeals to you, you might be a good fit for a CRC. Similarly, CRCs are making an average of $63,117 in 2020. Most make between a range of $54,210 and $72,902, plus employee benefits.
While numbers tend to fluctuate between cities and states, there’s no denying that these are great salaries for an entry position. Since according to one of the largest global job recruitment sites, Glassdoor, the average base salary in America is $40,000. Starting with an annual salary of $60,000 is considered uncommon and on the high end of the spectrum.
After one to two years of experience on the job, most companies provide CTAs and CRCs opportunities for professional development and promotion. Many become Clinical Research Associates, or CRAs. Indeed reports that the average salary of a CRA with one to two years of experience is $72,358. After building at least 6 years experience, a seasoned CRA should expect to earn $110,102 a year. If you would like to make more money, you can consider becoming an individual contractor CRAs. They can earn up to $300,000 in a year.
You are a science professional wanting to change careers and don’t want to go back to school
In clinical research, experience is often valued over degrees. Rather than what you didn’t study in college, hiring managers are more interested in what you have done in the past and how they can integrate you into their company.
This includes getting certified through clinical research courses, but more so what you learn from the courses you take. CCRPS offers the most in-depth CRA and CRC training so that there's tons to talk about during the interview and a working bank of knowledge during the first few months of the job. Explore more specialized certifications like ICH-GCP, Advanced Clinical Research Project Manager Certification, and Advanced Principal Investigator Physician Certification to further enhance your qualifications.
While graduate programs can help point you in the right direction, you don’t need a master’s degree to succeed in clinical research. In fact, certain positions don’t even require a bachelor’s or associate’s degree; they have certification in clinical research.
Applying to CRC and CTA positions are one of the most common segways into higher positions in clinical research. CRCs don’t need a bachelor’s or associate’s degree to get their foot in the door. While both CTA and CRA positions require a bachelor’s degree, they don’t have to be in the life sciences.
One of the best ways to gain experience and stand out from the crowd is to have on-site experience. If you need advice on how, Dan Sfera, the CEO of DSCS CRO Clinical Research Services, recommends getting started by interning or volunteering at clinics and research sites to build connections and experience.
Sometimes, the easiest way to get involved is to offer services like patient recruitment and social media management in exchange for opportunities to build your CV. By appealing to a site’s needs, this will help you get your foot in the door and build the connections and resume you need.
Another great way of adding experience to your resume is by training throughcertification courses. When employers see that you have taken the time and effort to understand how to be the best in their field, they are more far likely to hire you. At CCRPS.org, we offer seven courses and certification trainings to give you an advantage. Most 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 Joint Commission by the AMA, ANCC, and various other organizations to provide 17.5 CME credits through our CRA Certification and CRC Certification.
6. You are switching careers
Switching career fields can be nerve wracking. However, it is also an opportunity for you to be a unique candidate. Whether you come from a closely-related background, like medicine or nursing, or something completely different, there are ways you can advocate for yourself in front of employers.
If you already have a background in medicine (nonclinical doctor, unmatched MD), your knowledge of healthcare and your passion for patient health will make for a smooth translation into clinical research. In addition, your RN or MD degrees will help you gain a competitive edge and allow you to climb higher positions, such as the PI, who is the primary researcher of an operation.
On the other hand, if you come from a less relevant field but feel passionate, you can still leverage yourself to be exactly what the clinical research field needs. For example, if you are a teacher, your communication and interpersonal skills will be your keys to success. If you are a lawyer, your ability to draft and read papers will far surpass the average candidate.
If you studied mathematics, you are a skilled problem solver. If you are a translator, your language skills are valuable and will help you get into roles that require it. In short, whatever skills helped you succeed in your previous positions, you can bring it with you to clinical research.
7. You want to make a difference in disease outcomes and patient care
There are two types of people in the world: ones who accept the world as it is, and ones who strive to change it. In the last 50 years, science and medicine have gone through a series of drastic changes. However, anyone who works behind the scenes will tell you that medical breakthroughs are not miracles. Clinical research is the culmination of human effort and intelligence.
The fruits and labor of the ever-expanding industry are proof that if enough people care about the world, then they can change it. While there are many good reasons to work in clinical research, if you want the privilege to enrich the lives of others, there is a place for you in this field.
If you want to take a sneak peak at employers and opportunities near you, jobs sites like Indeed are a great resource.
Here are links for aspiring CRAs, for CRCs, and for CTAs. (Note: CTAs are often referred to Clinical Research Assistants, not to be confused for Clinical Research Associates)