Senior Clinical Research Coordinator

Job Summary

Senior Clinical Research Coordinators independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. They provide leadership to lower‑level clinical research coordinators and/or other support personnel. The position is responsible for, and critically important to the overall operational management of clinical research activities. It directly manages a diverse portfolio of research activities for one or more studies, which may include multicenter clinical trials (both NIH and industry‑sponsored), local investigator‑initiated clinical trials, and programmatic clinical research activities such as a clinical database and biorepository.

The incumbent may perform expert integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base and substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH). The role reports to a Research Manager, or on‑site to a Principal Investigator (PI) or Director, and includes ensuring IRB approval and compliance, contract generation and negotiation, subject recruitment, study testing, enrollment, and overall administrative leadership of clinical research.

The incumbent is responsible for creating and implementing quality improvement processes and maintaining the program’s reputation for excellence.

The Department of Emergency Medicine (DEM) provides emergency medical care to over 177,000 patients annually at the UCSF Medical Center at Parnassus, UCSF Benioff Children’s Hospitals at Mission Bay and Oakland, and Zuckerberg San Francisco General Hospital and Trauma Center. DEM administrative and research staff support the work of 97 full‑time and 50+ part‑time attending physicians, a residency program, fellowship programs, and over 300 house staff and students each year.

Our vision is to be the leader in compassionate, innovative and equitable emergency care for all people at all times.

• Bachelor’s degree in a related area and/or equivalent experience/training.
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting them to meet current recruitment goals.
• In‑depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent interpersonal, verbal and written communication skills.
• Ability to analyze complex and non‑routine issues requiring innovative solutions.
• Ability to operate effectively in a changing organizational and technological environment.
• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate the team to meet deadlines.
• Ability to interpret and apply policies and regulations.
• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
• Experience using database software, such as MS Access or File Maker Pro.

• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow‑up.
• Experience in risk management regarding study subjects, federal and non‑federal sponsors and regulating bodies.
• Experience with grant application procedures, personnel documentation, contract…