Sr. Clinical Research Coordinator - Breast Oncology

UCSF•San Francisco, CA

2d•$49 - $79

About The Position

The Senior Clinical Research Coordinator supports the Breast Oncology program by coordinating and managing clinical research studies, including study activation, amendment submissions, and activation and oversight of investigator-initiated trials with subsites. The role is accountable for the operational administration of one or more studies and may provide leadership to clinical research coordinators and other support personnel. The position manages a diverse portfolio that may include multicenter NIH- and industry-sponsored clinical trials, local investigator-initiated trials, longitudinal cohort studies, clinical databases, and biorepositories. Working with investigators, clinicians, staff, administrators, University committees and departments, sponsors, coordinating centers, and regulatory agencies, the incumbent ensures that research is conducted efficiently, safely, and in compliance with applicable requirements. Reporting to a Principal Investigator or Director, the coordinator may be responsible for CHR approval and compliance, contracts and budgets, recruitment and enrollment, study testing, audit readiness, quality improvement, financial oversight, and leadership of research personnel. The position is part of the UCSF Helen Diller Family Comprehensive Cancer Center, which integrates laboratory, clinical, patient-care, and population research. Its work is guided by precision medicine and precision population health.

Requirements

BS/BA degree in a related area, or equivalent experience or training.
Significant project and clinical trial management experience, or progressively responsible experience in a related position that includes 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 from 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 populations, independently identifying recruitment leads and meeting recruitment goals.
Project management skills to oversee clinical trials program administration and knowledge of human-subject recruitment strategies.
Exceptional analytical skills and demonstrated interpersonal, verbal, and written communication skills.
Ability to analyze complex, non-routine issues and develop innovative solutions.
Ability to work effectively in changing organizational and technological environments.
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 preparation and presentation of financial and quantitative analyses, projections, and budgets.

Nice To Haves

Fluency in spreadsheet software and ability to independently develop complex spreadsheets; demonstrated audit preparation, execution, and follow-up skills.
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 from the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

Responsibilities

Develop project plans, coordinate project documentation and deliverables, report status, analyze project and staff performance, develop pricing and cost models, review and improve workflows and controls, prepare presentations, and monitor operational risks.
Assess potential clinical trial participation, evaluate infrastructure and staffing needs, negotiate pre-trial agreements and budgets, coordinate contract execution and ancillary services, train staff, assign tasks, and ensure compliance with local and federal research laws.
Maintain clinical trial compliance and audit readiness; coordinate amendments and study files; recruit patients and track enrollment; support study closeout; and ensure study documentation and storage meet legal requirements.
Prepare and oversee CHR applications and renewals, respond to CHR revision requests, coordinate protocol changes with sponsors, and ensure timely reporting of protocol violations and adverse events.
Respond to study requests and reviews from sponsors, monitors, the FDA, and other entities, including complex audits.
Manage longitudinal cohort study infrastructure, including databases, space, equipment, and specimen storage and transportation; coordinate cohort activities and collaborate with external academic, clinical, and industry partners.
Contribute to or lead scientific presentations and publications and may contribute to grant proposals.
Manage research risk and compliance, advise and train employees and leadership, manage audits, and help establish and maintain quality improvement processes.
Assist with recruitment and training of personnel; mentor coordinators and assistants in recruitment, scheduling, visits, subject characterization, and data entry; provide training on research laws and guidelines; and help manage personnel needs.
Monitor budgets, invoices, reimbursements, and billing accuracy; 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.