Clinical Research Supervisor

Job Description

Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection.

The Department of Surgery Clinical Research Core supports a large and diverse portfolio of more than 80 active clinical research studies across multiple surgical divisions, including Vascular Surgery, Cardiac Surgery & Lung Transplantation, Thoracic Surgery, Surgical Oncology, General Surgery, and Endocrine Surgery. The Clinical Research Supervisor II serves as an operational leader within the Clinical Research Core and is responsible for managing an assigned portfolio of clinical research studies, investigators, and Clinical Research Coordinators (CRCs). This position provides full operational oversight throughout the study lifecycle, including feasibility assessment, study startup, regulatory implementation, financial oversight, enrollment management, quality assurance, study conduct, and closeout, while also overseeing staffing, performance management, programmatic workflow, and financial stewardship for assigned studies. The supervisor serves as the primary operational contact for assigned investigators and sponsors and is accountable for ensuring studies are conducted efficiently, compliantly, and in accordance with departmental objectives. Collaborates with fellow Clinical Research Supervisors and Clinical Research Core leadership to develop operational strategies supporting the Clinical Research Core, including staffing models, study portfolio management, workload forecasting, study startup planning, resource allocation, program development, and continuous process improvement. Exercises independent judgment in managing assigned portfolios while collaborating with leadership on complex operational, financial, or programmatic initiatives.

Department Overview:

The mission of the UCSF Department of Surgery is threefold: to develop the next generation of leaders in surgery; to provide outstanding quality clinical care that is cost effective, yet compassionate; and to make significant advances in scientific knowledge and clinical practice through basic and clinical research. Care of patients is what attracted our faculty and residents to surgery, and it continues to be our main focus.

The Department is comprised of eleven divisions that include Adult Cardiothoracic Surgery, General Surgery, Pediatric Cardiothoracic Surgery,Pediatric Surgery, Plastic & Reconstructive Surgery, Surgical Oncology, Transplant Surgery, and Vascular & Endovascular Surgery. Our surgeons provide care at locations throughout greater San Francisco including: UCSF Medical Center at Parnassus (Moffitt-Long Hospital), UCSF Medical Center at Mt. Zion, UCSF Medical Center at Mission Bay, UCSF Benioff Children's Hospital in Oakland, Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco VA Medical Center, and Alameda County Medical Center in Oakland. Our residents also rotate through UCSF Medical Center, Kaiser Permanente, and California Pacific Medical Center.

Qualifications

Required Qualfications - Bachelor's degree in related area. - Minimum of 3 years of Lead/Supervisory/Manager experience. - Minimum of 5 years of relevant experience. - Broad 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. - Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate. - Excellent 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. - Comprehensive knowledge of clinical research operations including clinical trial coordination, regulatory compliance (FDA, ICH-GCP, IRB), adverse event and protocol violation reporting, and quality data submission across diverse study types (IND, device, investigator-initiated, and federal). - Demonstrated experience supervising and managing clinical research staff, including hiring, onboarding, training, performance evaluation, and workload management across a multi-study, multi-division research portfolio. - Experience with study startup activities: feasibility review, IRB submissions (initial, amendments, modifications, SAEs), coverage analysis, budget development, and clinical trial contract execution. - Knowledge of research billing compliance, including billing trigger identification, invoice tracking, charge dispute resolution, and coordination with post-award finance teams. - Proficiency with REDCap, clinical trial management systems (CTMS), and EHR-based research platforms; ability to generate reports and conduct quality assurance reviews of data entry and regulatory documentation. - Demonstrated ability to develop, implement, and maintain standardized SOPs, training programs, and quality improvement processes across a large, complex research program. Certifications - Clinical Trial Professional certification from a professional society within one year in position; CCRP certification (through SOCRA). Preferred Qualifications - Advanced degree.