Clinical Research Associate
Job Summary
Responsible for creating, implementing, and maintaining clinical trials. Writes protocols, case report forms, and consent forms. Recruits and selects investigators and ensures good clinical practices are followed.
Primary Responsibilities
- Design, implement, and monitor clinical trials.
- Prepare integrated medical reports, periodic reports, New Drug Applications (NDAs) and Biological License Applications (BLAs).
- Recruit and select new investigators.
- Ensure case report forms are reviewed and submitted in a timely manner.
- Contract research organizations and vendors.
- Design and write protocols.
- Create informed consent forms for trials.
- Monitor investigator performance and adherence to protocols.
- Address enrollment problems.
- Write integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) and Biological License Applications (BLAs).
- Prepare and present documents of scientific meetings.
- Set up study centers and ensure each center has the trial materials.
- Visit the study centers throughout the trial on a regular basis.
- Check the patient data in the case report forms (CRFs).
- Validate and collect completed CRFs from hospitals and general practices.
- Discuss results with statistician.
- Close down study centers upon completion of trial.
- Write up reports after analysis has been completed.
- Verify that the rights and well-being of human subjects are protected.
- Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment.
- Verify that the investigator followed the approved protocol and all GCP procedures.
