Purpose (Objective):
The Clinical Research Coordinator is an essential team member in the conduct of dietary, exercise and pharmaceutical studies. This position acts as a point person for the clinical-study site, overseeing all operational responsibilities for the successful launch, enrollment, maintenance and completion of clinical projects. This position will report to the Clinical Site Manager.
Main activities:
Recruit, screen and enroll clinical study participants.
Obtain proper written informed consent from each study participant prior to participation in the study.
Schedule and complete defined activities of the studies completely and accurately.
Develop source documents and tools specific to the protocol.
Accurately complete source documents/case report forms, study medication and product accountability.
Train and brief current and new staff on all operational policies and procedures of the study, ensuring each person understands his/her role and responsibilities in the study. Ensure that the clinical trial is conducted according to the investigational plan (protocol) and Good Clinical Practices.
Meet and communicate with the Sponsor and/or their designee regarding the conduct of the study.
Inform Institutional Review Board and Sponsor as appropriate of relevant adverse events.
Successfully interact with the clinical research team.
Maintain a high level of knowledge and understanding of assigned protocols.
Support the corporate quality and continuous improvement process (TQM).
Perform other duties as needed.
Communication: