Clinical Research Coordinator
Role of the Clinical Research Coordinator in the Management of Rheumatic Diseases
The clinical research coordinator (CRC) presents, explains, and guides patients through clinical research trials. CRCs comprise the workforce for most clinical research trials. CRCs will interact directly with patients under the direction of a principal investigator (PI).
What Does the Clinical Research Coordinator Do?
- Understand the study’s full protocol, operations manual, policies, and procedures
- Be involved in the informed consent process, which involves answering questions regarding the study, collecting signatures and dates, or making sure the informed consent forms are correctly completed
- Responsible for pre-screening/screening of patients that may qualify for the study (during this process, the CRC will review patient information to see if the inclusion and exclusion criteria are met for possible future research participants)
- Contact possible research participants to see if they are willing to participate in the study
- Provide each study participant with a clear understanding of when future visits will occur, as well as help maintain the study’s protocol-specific timelines
- Coordinate, assist, or complete any tests and/or procedures the PI has assigned
- Document and report all information per the study’s protocol in a timely manner
- Stay in constant contact with the study’s sponsor, PI, and study participants
- Always operate in a professional manner following the Good Clinical Practice (GCP) and Health Insurance Portability and Accountability Act (HIPAA) guidelines at all times
- Collect all appropriate information required by the study protocol
- Coordinate the participants visits, procedures, and tests
- Be responsible for full and accurate study data documentation
- Stay in constant contact with the PI to ensure daily activities are being completed per protocol
- Assist with the study closeout and appropriate storage of study information
Where Does a Clinical Research Coordinator Work?
What Kind of Training Does a Clinical Research Coordinator Have?
- Most CRCs have at least a bachelor's degree, but this is not always required.
- National certification is available for CRCs, but it is usually not required.
This information is provided for general education only. Individuals should consult a qualified health care provider for professional medical advice, diagnosis, and treatment of a medical or health condition.