Associate Director for Clinical Research Programs

Job Description

Under the supervision of the Clinical Research Support Office (CRSO) Director, the Associate Director for Clinical Research Programs oversees the day‑to‑day staffing operations of the research programs, including Clinical Research Managers, Protocol Project Managers, and Clinical Research Coordinators. The Associate Director may supervise other levels of clinical research staff if coverage for vacancies is required. This role includes developing and hiring, training and staffing for the 14 centralized oncology programs throughout the HDFCCC reporting to the CRSO.

The Associate Director will manage 5‑7 direct reports at the Clinical Research Manager and Clinical Research Supervisor levels and provide management oversight of approximately 40 FTE clinical research staff (Clinical Research Supervisors, Senior CRCs, and CRCs). Responsibilities include developing workflows and training for all staff, screening and interviewing potential Clinical Research Managers and assisting with interviews for Clinical Research Supervisors, Clinical Research Coordinators and Senior CRCs while maintaining personnel files and performance evaluations per UCSF/Cancer Center HR policies.

The Associate Director will oversee the development of job descriptions, recruitment of CRC positions (up to 30 annually), oversight of study coordination, and assurance of efficient workflow in the CRSO and across partnering UCSF and external stakeholders. They will maintain strong relationships with campus and external partners to develop cohesive services and policies, providing opportunities for collaboration and open communication with Division Managers, Directors and Principal Investigators.

Working with the Education and Training Manager, the Associate Director will oversee staff training quality and onboarding for new hires, develop and oversee metrics for workload and staffing, including timelines for study activation, accrual and data completeness. They will oversee all protocol violation and audit reports and work with Clinical Research Managers to address staff performance issues requiring coaching or other HR interventions.

The Associate Director will implement research policies and procedures across the HDFCCC, support the Data Safety Monitoring Committee in addressing non‑compliant processes, report team problems to faculty research leaders, and provide personnel management suggestions to assure protocol compliance with the Code of Federal Regulations, ICH Guidance on Good Clinical Practice, and UCSF Institutional policies.

This position also supports the CRSO with additional duties as assigned by the CRSO Director, CRSO Medical Director, Associate Director for Clinical Research, HDFCCC Chief Administrative Officer, and the Deputy Director of the Helen Diller Family Comprehensive Cancer Center.

Department Description

UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI). The HDFCCC integrates research and clinical work dedicated to laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state‑of‑the‑art patient care; and population research that can lead to improvements in prevention, early detection, and quality of life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Qualifications

• Master's degree in a related area and / or equivalent experience / training.
• Certification as a clinical trial professional from one of the professional societies within one year in position, such as ACRP or SoCRA, and has attended any of their seminars.
• 5+ years experience in managing clinical trials and developing procedures related to GCP and FDA regulations.
• Minimum of 5 years of supervisory/management/lead experience and demonstrated experience in training others, particularly in the field of research.
• At least 6 years of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
• Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
• Experience working with sensitive populations, preferably with oncology patients.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a trial setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials.
• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials.
• Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues.
• Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities.
• Demonstrated ability to work collaboratively with other cross‑functional teams and people with a wide range of educational backgrounds. Ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade.
• Demonstrates excellent problem‑solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution.
• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.
• Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial.
• Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software.

Preferred Qualifications

• 4‑5 years experience in protocol and research writing and research management.
• Experience in developing SOPs and program evaluations.
• Completion of an educational program in clinical trial management which offers a certification.
• Advanced practice nursing certifications, particularly in Public Health, Emergency Nursing and Basic Life Support.