Sr. Clinical Research Coordinator - Cardiology

About the Role

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 the overall operational management of clinical research activities, implementing a diverse portfolio of research activities 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.

Reporting to the Clinical Research Manager, the incumbent ensures CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment for multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts. This role exercises strong administration and management leadership of clinical research, ensuring optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution. The position also creates and implements quality improvement processes to ensure clinical research commitments are met and programs maintain a reputation for excellence.

Department Overview

The Division of Cardiology is one of the largest clinical, research, and training divisions of the Department of Medicine (DOM) at UCSF. The Division supports 60-70 active clinical trials through its Cardiology Clinical Research Unit (CCRU), covering phase I-IV and post-approval trials across pharmaceutical, device, preventative, and social behavioral research. Sub-specialty sections include:

• Adult Congenital Heart Disease
• Advanced Heart Failure, Transplant, and Pulmonary Hypertension
• Cardiac Electrophysiology
• Critical Care Cardiology
• Cardio-Oncology and Immunology
• Echocardiography and Cardiac Imaging
• General Cardiology
• Interventional Cardiology
• Prevention

The Division operates clinical practices across multiple sites, conducts basic and clinical research, and educates medical students, residents, and clinical fellows through ACGME and non-ACGME training programs. It comprises 80 full-time faculty, 36 clinical fellows, several post-doctoral research fellows, and approximately 60 research support and administrative staff, with annual expenditures exceeding $22 million.

Responsibilities

• Lead and coordinate the administrative operations of one or more clinical studies, ensuring compliance with protocols, FDA regulations, and complex visit structures.
• Develop and implement recruitment strategies for diverse patient pools, adjusting approaches to meet enrollment goals.
• Oversee clinical research contracts and grants, including negotiation, approval, and financial oversight.
• Manage project plans, schedules, and deadlines, motivating teams to meet objectives.
• Analyze complex issues and develop innovative solutions to operational challenges.
• Prepare and present financial and quantitative analyses, including budgets and projections.
• Ensure audit readiness and respond to audit findings, including risk management for study subjects, sponsors, and regulating bodies.
• Collaborate with clinicians, investigators, clinical staff, administration, and external entities (e.g., industry sponsors, coordinating centers, FDA, NIH).
• Provide leadership to lower-level coordinators and support personnel, fostering efficiency and compliance.
• Utilize database software (e.g., MS Access, FileMaker Pro) for data management and reporting.

Requirements

• BS/BA degree in a related area or equivalent experience/training.
• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of hire.
• In-depth knowledge of clinical research contracts, grants, clinical trials, and FDA regulations.
• Project management skills to oversee administrative operations of clinical trials programs.
• Exceptional analytical, 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 projections.
• Significant experience in clinical trial management, regulatory compliance, and risk assessment.

Preferred Qualifications

• Fluency in spreadsheet software and ability to develop complex spreadsheets independently.
• Experience in audit preparation, execution, and follow-up.
• Experience with grant applications, personnel documentation, contract generation, and subcontracting, preferably at UCSF.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
• Experience in risk management for study subjects, sponsors, and regulating bodies.