Do you want to know how to become a Clinical Research Coordinator (CRC)? What does a Clinical Research Coordinator do? What qualities do CRCs need to succeed? You’ve come to the right place!
Today, the experts at Vitalief are here to guide you through everything you need to know. Let’s get started!
What is a Clinical Research Coordinator?
A Clinical Research Coordinator, commonly referred to as a CRC, is a person who organizes and manages clinical trials for pharmaceutical companies and academic institutions. These organizations rely on Clinical Research Coordinators to manage many aspects of their studies and make sure they’re done in compliance with all laws, regulations, and the study protocol.
What is a Clinical Research Coordinator’s Job Description?
The basis of a clinical research coordinator’s job description is doing everything it takes to ensure a clinical trial runs smoothly. Some of the responsibilities this includes are:
- Setting up clinical trial sites
- Training the site staff and patients
- Performing quality control checks throughout the study process
- Recruiting participants through community outreach programs
- Screening out ineligible patients at every step of the enrollment process
- Managing the informed consent process
Clinical Research Coordinators typically work as part of a team that includes statisticians, regulatory coordinators, primary investigators (PIs), and other members of the clinical research staff. They often have managerial responsibilities too.
Managing the Informed Consent Process
One of the most important tasks CRCs are responsible for is introducing the informed consent process to potential study participants. Without informed consent, clinical research cannot move forward ethically.
The informed consent process ensures that patients know the risks and benefits associated with a trial. It also provides the information necessary for them to make an informed decision. Plus, it provides an open dialogue between everyone involved.
This process requires the CRC to provide participants with all the necessary information about the study, such as:
- Aims and objectives
- The nature of their involvement
- The duration of the study
- The risks and benefits associated with participation
- Any other relevant details
The CRC must ensure that potential participants fully understand this information before they make the decision to participate in the study.
The CRC also assists in several other processes. These include:
- Developing study protocols
- Organizing meetings with investigators and other key stakeholders
- Ensuring compliance with applicable laws and regulations
- Maintaining accurate records throughout the course of the study
- Monitoring safety procedures
- Reporting any adverse events
The CRC, along with the Clinical Research Study Manager and the Regulatory Manager, may also be responsible for compiling and analyzing data from clinical trials and preparing reports to be submitted to ethics committees and regulatory bodies.
What Skill Sets are Required to be a Good Clinical Research Coordinator?
As a Clinical Research Coordinator, you are required to understand the complexities of clinical trials, as well as the drug development process. The best candidates for this job understand laboratory procedures, have administrative and computer skills, and have excellent communication skills. Clinical Research Coordinators must be detail-oriented and able to work under pressure with strict timelines.
As a Clinical Research Coordinator, the following skills will help you succeed in your role:
- Emotional intelligence, empathy, and compassion for others who are participating in a clinical trial
- Detail-oriented and know how to read and follow a protocol
- Exceptional communication and interpersonal skills since you will interact with the research team, the primary investigator, clinical staff, and the study participants in written and verbal communications
- Ability to multitask and excellent organizational skills
- Curious, willing to learn, and an analytical mindset
A Clinical Research Coordinator’s job description usually includes administrative tasks such as preparing budgets, filing paperwork, and handling correspondence.
What Education and Training are Required for a Clinical Research Coordinator Role?
In most cases, Clinical Research Coordinators must have at least a bachelor’s degree in life sciences or public health, as well as one year of laboratory experience.
They must also have up-to-date knowledge of relevant scientific literature and an understanding of statistics and experimental design principles.
Clinical Research Coordinators often serve as mentors to other employees in their organization regarding regulatory compliance standards and ethical issues that may arise during clinical trials.
Certifications Required for Clinical Research Coordinators
Professional certification requirements vary by employer, state, and the type of work a Coordinator does. There are numerous certifications that are designed to build a CRC’s skills and knowledge.
Micro-credentialing, such as a badging program, helps to expand knowledge and provide unique training experiences that are specifically designed for certain professional roles. Rutgers has a great program that is specifically geared toward Clinical Research Coordinators.
The Rutgers CRC Badging Program
The Rutgers Clinical Research Coordinator (CRC) Badging Program is an innovative program designed to provide certification and recognition for individuals who are looking to further their careers in the clinical research field. As part of the program, individuals must complete certain courses and demonstrate a deep understanding of clinical research protocols, practices, and standards.
To meet the requirements of the badging program, candidates will gain knowledge of the Clinical Research Coordinator job description. This includes understanding the essential functions of a research coordinator, such as:
- Developing, managing, and monitoring research protocols and studies
- Collecting and analyzing data
- Preparing reports and presenting results
- Maintaining accurate records and databases
- Troubleshooting any issues that may arise during the course of the study.
The Rutgers Clinical Research Coordinator Badging Program is a great way to demonstrate your expertise in the field of clinical research coordination and become more competitive in the job market. By obtaining your CRC badge, you can show employers that you have the knowledge and skill necessary to effectively lead clinical research projects.
Professional Career Paths for Clinical Research Coordinators
As a Clinical Research Coordinator, there are many opportunities for professional development. You interact with people in several different roles, from nurses to administrators. This exposure to diverse roles will enable you to explore a myriad of professional opportunities and help you determine the next step in your professional journey.
If you think you might be interested in pursuing this career path, now is a perfect time! Vitalief is always looking for strong candidates for this role. Check out our CAREERS page to see the different roles we are seeking to fill!