Assistant Director for Clinical Research Programs

Job Summary:

Under the supervision of the Associate Director for Clinical Research Programs, the Assistant Director, Clinical Research Operations, oversees the day-to-day staffing operations of their assigned research programs, including Clinical Research Managers, Clinical Research Supervisors and/or senior staff. The Assistant Director may be responsible for supervising other levels of clinical research staff if coverage for vacancies is required.

This includes developing and hiring, training and staffing for centralized oncology programs. There are 14 centralized oncology programs throughout the HDFCCC reporting to the CRSO. The Assistant Director is responsible for the day-to-day coordination and execution of clinical research operations for approximately 2 oncology programs, ensuring studies are conducted in accordance with protocol requirements, institutional policies, and regulatory guidelines

The Assistant Director will manage 4 – 5 direct reports at the Clinical Research Manager (Clin Rsch Supv 2), and Clinical Research Supervisor (Clin Rsch Supv 1) levels, provide management oversight of approximately 20-25 FTE clinical research staff (Clinical Research Supervisors, Sr. CRCs and CRCs).

Responsibilities include developing workflows and training for all staff, screening and interviewing all potential Clinical Research Managers and assisting (where required) with interviews for Clinical Research Supervisors, Clinical Research Coordinators and Sr. CRCs, while maintaining personnel files and performance evaluations per the UCSF/Cancer Center HR policies.

The Assistant Director will oversee through subordinates the development of job descriptions, recruitment of CRC positions (up to 20 annually), oversight of study coordination, assurance of efficient workflow in the CRSO and across partnering UCSF and external stakeholders.

The Assistant Director partners with the Associate Director and other leadership to support consistent practices across programs but does not have primary responsibility for developing enterprise-wide policies or metrics

The Assistant Director will work with the Education and Training Manager to oversee the quality of staff training and the on-boarding for new research hires.

The Assistant Director will be responsible for working on and implementing research policies and procedures across the HDFCCC.

The Assistant Director also supports the CRSO with additional duties as assigned by the Associate Director..

Department Overview:

The 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 the work of researchers and clinicians dedicated to four fundamental pursuits: 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.

Responsibilities

Qualifications

Required:

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. Demonstrated 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.

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.

Minimum of 5 years of supervisory/management/lead experience and demonstrated experience in training others, particularly in the field of research.

Experience working with sensitive populations, preferably with oncology patients.

Ability to cultivate relationships with multiple stakeholders at various levels of administration

5+ years experience in managing clinical trials and developing procedures related to GCP and FDA regulations.

Preferred:

Experience in developing SOPs and program evaluations

4-5 years experience in protocol and research writing and research management.