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.
- 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.