Job Summary The HDFCCC Clinical Research Support Office is looking for a Manager for the regulatory affairs team. The incumbent will provide direction to a team of regulatory analysts that submit industry and NCI sponsored trials to IRB and safety committees for approval according to established policies and guidance. The incumbent will establish strategic plans and objectives to meet departmental goals, create reports to ensure quality, and identify areas of potential for improvement.Regulatory affairs is a fast-paced, task-based environment. The successful candidate will be independent, detail-oriented with drive and focus, and a team player who consistently delivers results within designated timelines. The incumbent is expected to meet departmental standards and maintain a high level of customer service. Effective time management skills and a high degree of accuracy is necessary for success. This position functions as a source of communication between the IRB and the various research program personnel and faculty within the HDFCCC. The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC Clinical Research Support Office is a fast-paced work environment with a broad portfolio of clinical trials. The mission is to provide patients and their families with streamlined access to cutting-edge cancer therapies. In addition to providing compassionate, patient-centered care our team of clinicians and researchers is dedicated to improving outcomes for all patients. We combine basic science, clinical research, epidemiology, cancer control and patient care throughout the University of California, San Francisco.
The centralized regulatory affairs unit provides support to HDFCCC faculty and the disease programs to obtain regulatory approvals for translational and clinical research focused on the development of safe and efficacious therapeutic agents. Required Qualifications
Bachelor's degree in scientific or health care related area and/or equivalent experience.
Minimum 5+ years of related experience and 3+ years of lead/supervisory experience.
Managerial experience or equivalent leadership experience such as training of staff or leading meetings, preferably in oncology, clinical trials, or regulatory affairs.
Skill in managing established relationships with regulatory agencies such as the IRB, FDA, and NCI.
Proven knowledge or and experience applying Federal, State, and/or University-level regulations, policies, and guidance's to daily work.
Proficiency working with various databases, clinical trials management systems and MS office.
Ability to apply a complex array of issues, mental flexibility, and creativity.
Proven ability to work collaboratively in a team environment.
Demonstrated self-discipline and sound, independent judgement completing complex assignments.
Certified Clinical Research Professional (CCRP) Regulatory Affairs Certification
About UCSF 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 excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.
In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
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