Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.
The Department of Urology is seeking a Clinical Research Coordinator (CRC) Supervisor for the Urology Clinical Research Office. Under the supervision of the Urology Clinical and Translational Science (Research) Director (CRD), the CRC Supervisor is tasked with managing and facilitating the Urology Clinical Research Office day-to-day research study operations of their direct reports.
The CRC Supervisor reports to the CRD. Under their direction, the CRC Supervisor is responsible for training and supervising a team of approximately two to four clinical research personnel.
The CRC Supervisor is responsible for training and evaluating CRC performance in executing studies, direct oversight of data collection and reporting, monitoring study progress and milestones, and overseeing data monitoring activities in order to accomplish implementation of protocols within the program that meet federal, state and institutional policies and guidelines.
The CRC Supervisor assists the CRD in resolving operational, workload, protocol implementation, and data collection issues. The candidate will be a proven team-player with project management skills and mindset and have the ability to consistently deliver results on a tight timeline. The individual will assist with projects, patient coverage, and other CRC duties whenever necessary. In addition to supervising clinical research coordinators and personnel, the CRC Supervisor will serve as the main point of contact between the Principal Investigators (PI) and Sponsors from study launch (enrollment of first patient) through study follow-up/maintenance.
The CRC Supervisor will work with the CRD and direct reports to develop standard operating procedures and is responsible for training and mentoring CRCs to coordinate studies per Good Clinical Practice, with the goal to achieve optimal efficiency and productivity without jeopardizing patient care and data integrity.
The CRC Supervisor will supervise and support the pre-activation study tasks, that may include completing feasibility surveys; submitting protocols to the genito-urinary (GU) site committee or similar, Cancer Center Protocol Review and Monitoring Committee (if needed), and submitting the proposal, consent form, and study application to the Institutional Review Board (IRB) for review and approval; and processing new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, contract execution, and billing set up. The CRC Supervisor will supervise and support with coordinating study start-up, including training individuals for a specific study to ensure that pre-study activities prior to launch are completed, which may include mock study visits, testing study procedures, testing REDCap or other surveys, working with the Clinical & Translational Science Institute to do any pre-testing of processing instructions, etc. The CRC Supervisor will supervise and support with IRB amendments and continuing reviews for studies managed by the Urology department.
The final salary and offer components are subject to additional approvals based on UC policy.
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Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.
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- Advanced degree preferred.
- Certification as a clinical trial professional from one of the professional societies, such as ACRP or SOCRA and has attended any of their seminars.
- Prior experience in clinical research in various areas of oncology, particularly in medical oncology, lab based research.
- Prior experience with UCSF, particularly with research in the oncology setting, clinical trial billing, and institutional policies for study compliance and regulation.
- Prior experience working with Oncore, EPIC (APEX), and other data management systems.
- Must possess a solution-oriented attitude and be adaptable to quickly changing priorities.
- Bachelor's degree in related area and / or equivalent experience / training
- Minimum 3 years of related experience
- Minimum 1 year of management experience of leadership/supervisory/management experience
- At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
- Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
- 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 skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
- Critical thinking skills to evaluate issues and identify a potential solution.
- Clear and concise communicator; good verbal and written communication skills; both.
- 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.
- Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
- Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in urology oncology.
- NCI/CTEP requirements of clinical trials programs, especially in terms of reporting adverse events.
- Prior experience with various computer programs, like Microsoft Office, and clinical trial management systems.
- Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
- Supervisory experience or 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.
- Have excellent interpersonal skills, including but not limited to: communication, problem-solving, teamwork development, leadership, mentorship.
