Sr. Clinical Research Coordinator - Breast Oncology

University of California, San Francisco•San Francisco, CA

13h

About The Position

The Senior Clinical Research Coordinator independently coordinates and is accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. The role supports the Breast Oncology program with study activation, study amendment submissions, and activation and oversight of investigator-initiated trials with subsites. It has leadership responsibility for ensuring clinical research commitments are met and programs maintain a reputation for excellence. The position manages a diverse portfolio of research activities, which may include multicenter NIH- and industry-sponsored trials, local investigator-initiated trials, longitudinal cohort studies, clinical databases, and biorepositories. The coordinator integrates complex program activities and works with clinicians, investigators, clinical staff, administrators, University committees and departments, industry sponsors, coordinating centers, the FDA, and the NIH. Reporting to a Principal Investigator or Director, the incumbent may have central responsibility for CHR approval and compliance, contracts, recruitment, study testing, enrollment, operational efficiency, safety, financial oversight, and quality improvement. The position may lead and mentor other research personnel. The role is part of the UCSF Helen Diller Family Comprehensive Cancer Center, an NCI-designated comprehensive cancer center. The center integrates laboratory, clinical, patient-care, and population research, guided by precision medicine and precision population health.

Requirements

Bachelor of Science or Bachelor of Arts degree in a related area, or equivalent experience/training.
Significant project and clinical trial management experience, or progressively responsible experience in a related position, including regulatory and compliance responsibilities.
In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of hire.
Experience using database software such as MS Access or FileMaker Pro.
Demonstrated ability to develop and adjust recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads and meeting recruitment goals.
Project management skills to oversee clinical trial program administration and knowledge of strategies for recruiting human subjects.
Exceptional analytical skills for evaluating the importance and urgency of problems; excellent interpersonal, verbal, and written communication skills.
Ability to analyze complex and non-routine issues and develop innovative solutions.
Ability to operate effectively in a changing organizational and technological environment.
Ability to assess and respond to audit risk, develop project plans and schedules, and motivate teams to meet deadlines.
Ability to interpret and apply policies and regulations.
Financial analysis skills, including preparing and presenting financial and quantitative analyses, projections, and budgets.

Nice To Haves

Fluency in spreadsheet software and ability to develop complex spreadsheets independently.
Demonstrated skills in audit preparation, execution, and follow-up.
Experience in risk management involving study subjects, federal and non-federal sponsors, and regulatory bodies.
Experience with grant application procedures, personnel documentation, contract generation, and subcontracting, preferably at UCSF.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

Responsibilities

Develop project plans; interview key sponsors; deliver project results; provide status reports; coordinate project documentation and archiving; analyze project and staff performance; develop pricing and cost models; review and improve business processes, workflows, and controls; prepare study presentations; and monitor operational risks.
Manage clinical trial initiation and operations, including assessing trial participation and execution capacity, negotiating pre-trial agreements and budgets, coordinating contracts and ancillary departments, training staff, assigning tasks, and maintaining documentation and regulatory compliance.
Provide ongoing staff training, coordinate amendments, maintain study files and audit readiness, recruit patients, track enrollment, and lead study close-out activities.
Ensure systems and documentation support compliance with regulatory requirements and safe clinical research, including current CHR documents, new applications, renewals, revisions, protocol changes, violation reporting, and adverse-event reporting.
Respond to study requests and reviews from sponsors, monitors, the FDA, and other entities, including complex audits.
Manage infrastructure for longitudinal cohort studies, including databases, space, equipment, and specimen storage and transportation; coordinate cohort and clinical trial activities; and collaborate with universities, clinical entities, and industry on study data.
Contribute to or lead scientific presentations and publications and contribute to grant proposals as appropriate.
Protect the University from noncompliance and potential litigation by ensuring contract, legal, hiring, and supervision compliance; advise and educate employees and leadership; manage audits; and help maintain quality improvement processes.
Assist with recruitment and training; mentor coordinators and assistants in recruitment, scheduling, visit management, subject characterization, and data entry; and help manage personnel needs.
Monitor budgets, invoices, reimbursements, and billing; guide subjects through financial processes; review budget reports; maintain study budgets and projections with the PI; ensure compliant use of research funding; and assist with grant budget development.