Clinical Research Coordinator (GCP Role) Job Duties:
Maintain a safe, fast-paced, and positive work environment.
Draft study protocols, Informed Consent Forms, and other trial-supporting documents for IRB submissions of GCP-compliant studies.
Obtain informed consent from human test subjects in a GCP setting.
Involves sitting down with a subject for up to 1 hour and walking them through the Informed Consent documentation and answering any questions they may have regarding their participation in a Clinical Study.
Obtain background health information from prospective study subjects to evaluate their eligibility to participate in Eurofins CRL, Inc. clinical trials.
Obtain HIPAA Authorization from prospective study subjects.
Interview prospective study subjects.
Coordinate with Principal Investigator to ensure adequate subject recruitment has been met for each study.
Interact directly with clients on an as-needed basis.
Assist in training of other personnel as requested.
Ensure safety and compliance with governmental regulations.
Interact with FDA and clients as needed in the event of an inspection/audit.
Follow all applicable Good Clinical Practice Regulations.
Perform delegated duties assigned by Principal Investigator.
Responsible for the technical conduct of assigned tasks.
Make certain that all experimental data, including observations of unanticipated responses of the test microorganism are accurately recorded and verified.
Follow all protocol and SOPs, reporting any deviations promptly to Principal Investigator.
Note and inform Principal Investigator of any unforeseen circumstances that may affect the quality and integrity of the study when they occur.
Prepare microbiological media and supplies.
Assist with basic laboratory needs, such as cleaning, organization, or equipment validation.
Maintain and regularly update resume and training records.
Transfer all raw data, documentation, protocols, and final reports to the Archivist at the close of the study.
Other duties as needed.