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 may 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 has direct responsibility for implementing 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/or programmatic clinical research activities, such as a clinical database and biorepository. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, 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), exhibiting an in-depth knowledge of specific programs.
Reporting to a Principal Investigator (PI) or Director, the incumbent may have central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.
Department Overview: Overview
The Department of Dermatology, School of Medicine, is responsible for a broad range of patient care, teaching, research and public service responsibilities. The Department provides medical students, residents, and post-doctoral fellows in the School of Medicine, with programs in research, patient care, teaching and public service. The Department is comprised of four distinct clinical sub-units located at the Ambulatory Care Center, San Francisco General Hospital, Mount Zion, Mission Bay and the Veteran’s Administration Medical Center and consists of 38 full-time faculty, 40 researchers, 40 staff, 13 residents and 6 clinical fellows. These operations are administered through various sites, interdependent sub-units, which are coordinated through a centralized Administrative Core.
Key Responsibilities
%
of time (Nothing less than 5%)
Essential Function (Yes/No )
Key Responsibilities
(To be completed by Supervisor)
30
Yes Research Operations Management:
Develop project plans, interview key sponsors, and deliver tangible project results
Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
Design and perform ad-hoc performance analysis of the projects and the project staff
Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects
Perform business process review, operational reviews and design and implement workflow and controls
Develop project-related presentation material for study
Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)
40
YES Clinical Trials…