The HDFCCC is looking for a Senior Regulatory Specialist, experienced in clinical trials and regulatory submissions, to work with investigators, study teams and regulatory bodies to obtain human subjects and safety committee approvals for oncology clinical trials. Under the direction of the Regulatory Affairs Manager, they will review cooperative and industry sponsored protocols, draft informed consents (ICFs) on sponsor templates, and submit protocols to both internal and external IRBs. The candidate will ensure that the trials are in compliance with federal, state, and University mandated laws, regulations and policies pertinent to research involving human subjects.
Using research compliance concepts, the Senior Regulatory Specialist will apply organizational policies and procedures to review and / or pre-review moderately complex, minimal, and high risk oncology research protocols. Must be able to work independently without a great deal of supervision or oversight for routine assignments. The candidate will communicate frequently and work closely with members of the regulatory unit, HDFCCC staff and faculty, and internal and external IRBs to gain human subjects approval for protocols and their associated Informed Consent Forms (ICFs) in a timely manner.
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.
