Associate Director for Clinical Research Programs

University of California San Francisco•San Francisco, CA

23h

About The Position

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 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 Associate Director will manage 5-7 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 40 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 Associate Director will oversee through subordinates the development of job descriptions, recruitment of CRC positions (up to 30 annually), oversight of study coordination, assurance of efficient workflow in the CRSO and across partnering UCSF and external stakeholders. Under the guidance of the CRSO Director, the incumbent will maintain strong relationships with campus and external partners to develop cohesive services and policies. This requires providing opportunities for collaboration and open communication with Division Managers, Directors and Principal Investigators. The Associate 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 Associate Director will develop and oversee metrics for workload and staffing, including but not limited to timelines for study activation, accrual and data completeness. This work effort will be enforced through the supervision of the Clinical Research Manager in each oncology research program. In addition, the Associate Director will oversee all protocol violation and audit reports by meeting and working with the Clinical Research Manager. The Clinical Research Managers will also report to the Associate Director all staff performance issues that may require coaching, counseling, and other HR interventions. The Associate Director will be responsible for working on and implementing research policies and procedures across the HDFCCC. This position also supports the Data Safety Monitoring Committee in addressing non-compliant processes from a particular staff member or a research group. This position will report to faculty research leaders any team problems and provide suggestions for personnel management to assure protocol compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies. The Associate Director 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. The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The salary range for this position is $140,300 - $210,400 (Annual Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Requirements

Master's degree in 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.
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.
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
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.

Responsibilities

Oversees the day-to-day staffing operations of the research programs, including Clinical Research Managers, Protocol Project Managers, and Clinical Research Coordinators.
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.
Oversee through subordinates the development of job descriptions, recruitment of CRC positions (up to 30 annually), oversight of study coordination, assurance of efficient workflow in the CRSO and across partnering UCSF and external stakeholders.
Maintain strong relationships with campus and external partners to develop cohesive services and policies.
Work with the Education and Training Manager to oversee the quality of staff training and the on-boarding for new research hires.
Develop and oversee metrics for workload and staffing, including but not limited to timelines for study activation, accrual and data completeness.
Oversee all protocol violation and audit reports by meeting and working with the Clinical Research Manager.
Responsible for working on and implementing research policies and procedures across the HDFCCC.
Supports the Data Safety Monitoring Committee in addressing non-compliant processes from a particular staff member or a research group.
Report to faculty research leaders any team problems and provide suggestions for personnel management to assure protocol compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies.
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.