What are the responsibilities and job description for the Clinical Research Specialist I, Seidman Cancer Center position at University Hospitals?
Description A Brief Overview
Under the direct supervision of the Principal Investigator and senior study staff, assists with the coordination and implementation of assigned clinical research trials.
What You Will Do
- Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%)
- Performs assigned activities related to clinical research studies including but not limited to : Screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes source documents and case reporting forms. (30%)
- Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (20%)
- Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%)
- Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%)
- Performs other related duties as assigned or required. (10%)
Additional Responsibilities
