Sr. Clinical Research Coordinator - Breast Oncology Program

About the Role

Senior Clinical Research Coordinators with the Breast 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 the overall operational management of clinical research activities, 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
• Programmatic clinical research activities, such as a clinical database and biorepository

Positions at this level perform expert integration of multiple complex programmatic activities, applying sophisticated medical knowledge, leadership skills, and working effectively with various stakeholders at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and external entities (industry sponsors, coordinating centers, FDA, NIH).

Reporting to a Principal Investigator (PI) or Director, the incumbent ensures CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, study testing, and enrollment for multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts. The role involves strong administration and management leadership of clinical research, research coordination, and may include leading experienced personnel to optimize systems for efficiency, compliance, safety, financial oversight, and contractual expertise.

Responsibilities

• Develop and implement recruitment strategies in complex environments and diverse patient pools, adjusting strategies to meet recruitment goals.
• Oversee the administrative operations of the clinical trials program, including project management and knowledge of human subject recruitment strategies.
• Ensure compliance with FDA regulations, clinical trial protocols, and complex visit structures.
• Analyze complex issues, develop innovative solutions, and interpret and apply policies and regulations.
• Assess and respond to audit risks, develop project plans/schedules, and motivate teams to meet deadlines.
• Prepare and present financial and quantitative analyses, including financial projections and budgets.
• Manage regulatory and compliance responsibilities for clinical trials and projects.
• Create and implement quality improvement processes to maintain excellence in all activities.

Requirements

• Bachelor’s 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.
• Experience using database software, such as MS Access or FileMaker Pro.

Skills

• Exceptional analytical skills to evaluate the importance and urgency of problems.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to operate effectively in a changing organizational and technological environment.
• Financial analysis skills, including preparing and presenting budgets and financial projections.

Preferred Qualifications

• Two years of experience with breast cancer clinical trial coordination.
• 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 generation, and subcontracting, preferably at UCSF.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals, or ability to obtain certification within one year of hire.