Sr. Clinical Research Coordinator - Pediatric Oncology

Senior Clinical Research Coordinators with the Pediatric Oncology program 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: 

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is the only cancer center in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute. We combine basic science, clinical research, epidemiology, cancer control and patient care throughout the University of California, San Francisco. Currently, the HDFCCC conducts over 700 clinical trials across various departments

% 

of time

Essential Function (Yes/No)

  

Key Responsibilities

(To be completed by Supervisor)

10

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.)

 

50

Yes

Clinical Trials Management:  

• Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
• Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects’ options, and ensure that documentation and storage of study files meets legal requirements.
• Ensure optimal systems are in place to ensure compliance with regulatory requirem