The Clinical Research Coordinator (CRC) assists the Clinical Investigator in conducting a clinical trial at a research site. A CRC is often called a Study Coordinator. A CRC job often provides a person’s first exposure to a career in clinical research.
For small studies, the site team may include only an Investigator and a CRC. The CRC helps the investigator identify potential participants for the study; gathers and organizes the study materials (the protocol and Investigator’s Brochure, etc.); arranges the paperwork for IRB submission; works with the Investigator to develop the study budget; witnesses Informed Consents; schedules visits for the study participants; makes sure protocol procedures are completed at each visit; completes and submits case report forms; keeps track of study drug; and meets with CRAs who come to monitor the site.
For larger, more complex studies, the CRC may work with a site team including other CRCs; study nurses, sub-investigators, contracts and budget staff, and a pharmacist.
In both large and small studies, the CRC has an important role in working with the study subjects, with Investigators, with IRBs, with CRAs, and with representatives of the study Sponsor. It’s a great opportunity to learn how studies are done and to make a real contribution to study conduct.
If you look at hiring ads for Study Coordinators, you will find some of these activities listed:
Gather and file data from Investigational Review Board (IRB)
Schedule Screening and Follow-up visits
Assist subjects in attending study visits and completing diaries
Obtain and witness informed consent forms
Compile and enter case report form information
Keep records and dispense study drug and other study materials
Maintain files of correspondence with IRBs and Sponsors
Assist study monitors in accessing medical records at site
CRCs must have or must develop a knowledge of GCPs
CRCs must understand medical terminology
CRCs must develop skill with the Sponsor’s software for completing case report forms
CRCs may need to develop rapport with subjects and their families to assist them in coming to study visits and completing all study activities
And every ad wants someone who can
- be “detail oriented”,
- has computer experience with word processing and spreadsheet programs, e-mail, and various electronic data capture (EDC) systems. Since EDC systems may vary from study to study, a good CRC candidate should have some general understanding of the systems and an ability to learn on the job.
- good communication skills; sometimes the job requires someone with fluency in a second language.
Education and Training requirement can vary depending on the study and the institution. Some job descriptions ask for an Associate Degree others require a bachelor’s degree in science or health care.
Sometimes the CRC is expected to take on the role of Study Nurse as well as providing administrative support for the study. In these cases, the job description may state that candidates should be licensed nurses (RN, LVN, or LPN).
There may also be jobs for people with only a high school diploma (or HSED or GED). Some CRC jobs are part-time and these jobs often provide a way for students to get some clinical trial experience while earning their AA or bachelor’s degree. Students enrolled in nursing, pharmacy, and medical schools may also work as CRCs.
If you have some health care training and are looking for a CRC position, you might want to take a course (in person or online) to learn about clinical trials and GCPs (Good Clinical Practices). You want to be familiar with the vocabulary and regulations related to clinical trials before you go job hunting. I teach in a course for Clinical Research Certification sponsored by UC Berkeley Extension. While I think this is an excellent course, it is a major commitment and requires a significant financial investment. You will find similar courses across the US. I'd suggest that you start by search for information about "clinical research" and "Good Clinical Practices" online first and start learning what you can without a financial commitment until you are sure of your interests.
Being a CRC can be the start of a long career in clinical research. Some CRCs go on to become study nurses or Investigators. Some move to a pharmaceutical company or CRO and work as Clinical Research Associates. Others work long-term as CRCs taking on larger and more complex studies and additional responsibilities.
In my experience, it is easier to get a Clinical Research Coordinator position as your first job in clinical research because investigative sites are located across the country. Clinical studies are conducted in doctor’s offices, hospitals, or large medical centers. You may find a site nearby that needs assistance.
I would suggest that you look at job postings for CRCs on sites like Indeed, BioSpace, and Medzilla to see what opportunities exist near your home. I think you might also find it useful to conduct a search like, “Careers as a Clinical Research Coordinator” and look at some of the blogs posted by actual CRCs.
You can become certified as a Clinical Research Coordinator through organizations such as the Association of Clinical Research Professionals (ACRP). The ACRP is an organization for CRCs, CRAs, Clinical Investigators, Project Managers, and others who work in the Clinical Research industry. The ACRP website is a good place to learn more about the roles of the CRC and to get information about other jobs in the industry. The ACRP sponsors continuing education classes and regional and national meetings for clinical researchers.
“Clinical Research Coordinator Handbook, 4th Edition” Deborrah Norris, 2009, 157 pages, Plexus Publishing, $39.95
This is a link to a review of this handbook written by Norman M. Goldfarb, the editor of the Journal of Clinical Research Best Practices.