Job Description

We are looking to hire a Clinical Research Supervisor to help develop, shape and grow the clinical research team. The research program is a fast-paced environment and the successful candidate will be an independent, detail-oriented individual with drive and focus.

The candidate will be a proven leader with project management skills and mindset, experience in oncology clinical trials, and have the ability to consistently deliver results on a tight timeline. The candidate will have leadership skills and training experience to provide operational leadership to a group of Clinical Research Coordinators (~ 3-6 direct reports), while monitoring workload and productivity.

Under the direction of the Clinical Research Manager, the Clinical Research Supervisor is responsible for strategic planning in order to meet program goals, along with ensuring all reporting and study milestones are met including recruitment targets, data entry timelines, budget and sponsor requirements. This position also requires the candidate to be responsive to Principal Investigators and scientific oversight committees. Experience collaborating with senior leadership and research staff is a plus.

The success of the team is dependent on managing performance, maintaining morale, upholding consistency across disease programs in terms of workload and assignment management, as well as maintaining high quality customer service. To achieve service quality, the Clinical Research Coordinator Supervisor will work closely with staff to identify areas in need of training and development, review, and refreshers.

The Clinical Research Supervisor’s duties may also include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

Department Overview:

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a campus-wide multidisciplinary organized research unit whose goal is to enhance and integrate cancer related research and patient care at UCSF. The HDFCCC combines basic science, clinical research, epidemiology/cancer control and patient care from throughout the University of California, San Francisco system. The Cancer Center provides research resources to its 200+ members on the four main campus sites as well as other sites, and provides multidisciplinary cancer care to patients.

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

15

Yes

Supervises staff work assignments and schedules to meet clinical research goals and timelines. Meets regularly with assigned staff to set goals and ensure objectives are being met. Directly supervises subordinates' quality and quantity of work to ensure studies meet objectives and are compliant with all regulations. Advises employees regarding resolution of technical problems. Communicates and collaborates with cross-functional teams.

10

YesManaging through staff, has direct responsibility for delivery of key trial goals and objectives, including enrollment targets and outcome event adjudication. Monitors compliance with all policies and processes. Adheres to standards.

10

YesServes as main liaison between clinical trials and program leaders. Proposes solutions to difficulties arising from multidisciplinary research, implements structural changes that maximize time efficiency within the constraints of limited resources.

10

YesOversees a trial from inception through completion, including approvals, initiation (site visit coordination), protocol implementation, data management, writing publications and finalization of sponsor requirements. Prepares and approves final clinical trial documents, including protocol, brochures, training, reports, presentations, safety advisories, and manuals.

15

YesInterfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting.

10

YesAdministers fiscal, material and human resources within study budget. Plans and implements resource allocations to individual trials. Suggests ways to be more efficient. If necessary, requests additional resources. Manages revenue collection, invoicing, and reimbursement accounting.

5

NoReviews new budget proposals for feasibility with industry sponsors, creates internal budgets for grants, creates invoices, and reconciles budget spending and salary support. Reviews and monitors all research related charges to ensure budgetary compliance.

5

NoOversees and analyzes complex databases. Compiles data reports as needed. Provides team, investigators, and clinical fellows with guidance regarding study design and logistics (data collection forms, formatting of data, data management). Assists with publication of abstracts and manuscript. Viewed as an excellent resource for any related questions or concerns about the trial.

10

NoRecommends salary actions, promotions, and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. Recommends changes in staffing and changes to budget to ensure the efficient operation of the function. Participates in recruitment and orientation of new employees.

10

NoEvaluates assigned staff performance and competency. Defines individual development goals. Mentors professional staff, including employees that are learning a new area of clinical practice. Encourages assigned staff to further their knowledge through clinical education, and certifications.

100%

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

MINIMUM REQUIREMENTS:

• Bachelor's degree in related area and 2+ years of related and lead/supervisory experience and/or equivalent experience/ training.
• Clinical Trial Professional certification from a professional society within one year in position
• Working knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.
• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.
• Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.
• Clear and concise communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Ability to influence and negotiate.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.

PREFERRED:

• Advanced degree preferred.

LICENSE/CERTIFICATION:

• Clinical Trial Professional certification from a professional society within one year in position