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
s, 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 % of time Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 25 Yes Develops, manages and oversees the organizational, strategic and tactical aspects of a clinical trial program. Provides operational, clinical and project management oversight for assigned research. 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 FTE clinical research staff (CR Supervisor, Sr.
CRCs and CRCs). Developing workflows and training for all staff, screening and interviewing all potential Clinical Research Managers and assisting (where required) with interviews for 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
s, recruitment of CRC positions (up to 15 annually), oversight of study coordination, assurance of efficient workflow in the CRSO and across partnering UCSF and external affiliates. Oversee all protocol violation and audit reports by meeting and working with the Clinical Research Manager. Oversee the quality of staff training and the on- boarding for new research hires.
Through subordinate staff, develop and oversee metrics for workload and staffing, including but not limited to timelines for study activation, accrual and data completeness. The Assistant Director will manage /oversee all staff performance issues that may require coaching, counseling, and other HR interventions from their subordinate staff. 10 Yes Translates clinical research objectives, policies and procedures into an operational plan.
Develops ways to measure research productivity and quality. Establishes clinical research goals to ensure trial achieves pre-defined sponsor goals, study coordinating center goals and departmental objectives. Supports translation of clinical research objectives into program-level operations.
Assists in implementing operational plans and staffing models Monitors program performance and reports metrics to the Associate Director Identifies workflow issues and recommends improvements 10 Yes Follows operational processes in selecting methods and techniques for trials. Analyzes and reports success of research and suggests improvements. Monitor, evaluate and coordinate data from multiple systems to recommend new actions / procedures from research analysis.
Participates in preparation of manuscripts, abstracts and scientific presentations. The Assistant Director will be responsible for working on and implementing research policies and procedures across the HDFCCC. 10 Yes Designs and implements quality control processes for research programs, including regular program evaluations to meet department standards. Ensures study research personnel collect data and perform study assessments in a standardized fashion consistent with the study protocol.
Data Monitoring and Reporting Tracks and monitors program performance. Reviews data related to study activation, accrual, and data quality Escalates risks or delays to the Associate Director Assists in preparing summaries and reports Quality Assurance and Compliance Ensures adherence to established quality standards. Monitors compliance with protocols and regulatory requirements Assists in preparation for audits and supports follow-up actions Escalates significant compliance issues 10 Yes Manages program resources of assigned studies.
Manages systems and processes designed to ensure successful revenue collection, invoicing and reimbursement accounting. Conducts large project feasibility assessments. Analyzes risks, strategies and solutions.
Develops project timelines and key milestones for assigned projects. Recommend adjustments to budgets and vendor agreements as necessary. This work effort will be enforced through the supervision of the Clinical Research Manager in each oncology research program. 10 Yes Develops strategic plans for ensuring high-quality interactions with the ethical review boards, investigators, regulatory authorities, and vendors, leading to successful execution of clinical development plans and submissions for the trial.
Works collaboratively with Principal Investigator, internal and external partners and vendors. Manages integral committees to the study. Assesses policies and processes to ensure proposed project plan is compliant with applicable guidelines.
Revises research / trial documents so they are consistent with protocol revisions. Ensures reporting is consistent with external guidelines, university policies and regulations. 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. 10 Yes Represents the trial to study committees, partners, corporate / industry partners, regulatory and oversight agencies and the public as necessary.
As a technical lead, provides guidance to all levels of management on ways to improve effectiveness. Proactively recommend interventions / corrective actions to meet project goals. Maintains 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 5 Yes Determines salary actions, promotions and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. Proposes changes in staffing as needed.
Executes recruiting, hiring and onboarding, ensuring that new hires meet standards. 10 Yes Implements and administers employee evaluations that meet organization standards. Evaluates assigned staff and defines development goals. Promotes professional growth and advancement for staff.
Trains study team and provide certifications for the study. Seen as a role model by assigned staff. 100%
Full time · Day shift 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.