The Clinical Trials Project Manager I will have responsibility for all research administration activities of assigned clinical trials for the Clinical Research Administration Division of the KUMC Research Institute.
The Clinical Trials Project Manager acts as the central liaison between sponsors, institutional review boards, and researchers at the University of Kansas Medical Center. This position is responsible for the upkeep of division systems used to track research activities. This position acts in conjunction with the clinical care research team to provide regulatory and administrative services in performance of clinical research at KU Medical Center.Essential Functions
- Ensure that protocols, amendments, adverse event reports, investigational drug brochures, continuing reviews and other miscellaneous documents are approved by the Human Subjects Committee (HSC), hospital departments/committees, appropriate federal and regulatory oversight groups, as appropriate.
- Review the research protocol and prepare study specific consent forms.
- Maintain records and files in accordance with regulatory requirements.
- Ensure that all data is entered into the departmental database in a timely and accurate fashion.
Location/Region: Fairway, KS