Description
Responsibilities:- Assist with developing clinical study protocols, case report forms, informed consent forms and other study-related documents.
- Assist in study start-up, conduct and close-out activities.
- Act as one of the primary contacts between the company and multiple clinical sites. Maintain close contact with sites by telephone, correspondence and visits.
- Participate in investigator meetings.
- Instruct investigators, study coordinators and their personnel in regard to study protocol, regulatory requirements and conduct of the study.
- Arrange for the availability of adequate study supplies.
- Travel to clinical sites to monitor compliance with the study protocol, clinical trial material storage and accountability, GCP and FDA or other Health Authority regulations, and overall clinical objectives. Verify accuracy of clinical data through comparison of the case report forms to patient records at the site.
- Interact with personnel of Clinical Research Organizations as needed.
- Approximately 30-40% travel to sites throughout the year.
Requirements:
- Experience at a pharmaceutical company
- BS/BA