Role of the Clinical Research Coordinator in the Management of Rheumatic Disease

Clinical Research Coordinator

The role of the Clinical Research Coordinator (CRC) is to present, explain and guide patients through clinical research trials. CRCs comprise the workforce for most clinical research trials. The CRCs will interact directly with patients under the direction of a Principle Investigator (PI).

What does the Clinical Research Coordinator do?

A CRC may do the following:

  • Understand the study’s full protocol, operations manual, policies and procedures.
  • Be involved in the informed consent process. This could involve answering questions regarding the study at hand, collecting signatures and dates, or even making sure the informed consent forms are correctly filled out.
  • Responsible for pre-screening/screening of patients that may qualify for the study. During this process the CRC will review the patient’s 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 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 GCP and HIPAA guidelines at all times.
  • Collect all appropriate information required by the study protocol.
  • Coordinate the participants visits, procedures and tests.
  • Responsible for full and accurate study data documentation.
  • Stay in constant contact with the PI to ensure daily activities are being completed per protocol.
  • Assists with the study closeout and appropriate storage of study information.

Where does a Clinical Research Coordinator work?

  • Hospitals
  • Clinics

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, diagnoses and treatment of a medical or health condition.

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