Clinical Research Coordinator Cardiology

About the role

The Department of Medicine, Division of Cardiology has developed a clinical research infrastructure to increase industry-sponsored research, assist physicians in operationalizing investigator-initiated studies, and develop a general cardiology cohort study. This position supports ongoing and future clinical and translational research projects within the Division of Cardiology.

Under the supervision of the Clinical Research Supervisor, the incumbent will perform duties related to the support and coordination of clinical studies, with opportunities for training and advancement.

Responsibilities

• Support the management and coordination of single or multiple clinical research studies, depending on size and complexity.
• Act as intermediary between services and departments while overseeing data and specimen management.
• Manage and report on study results; create, update, and manage databases and comprehensive datasets.
• Coordinate staff work schedules to ensure proper coverage.
• Assist with training of Assistant Clinical Research Coordinators (CRCs) and support the Clinical Research Supervisor and/or Principal Investigator (PI) in overseeing other research staff.
• Manage PI’s protocols in the Committee on Human Research online system, including renewals, modifications, and implementation of new studies.
• Participate in the review and writing of protocols to ensure institutional review board approval and University compliance.
• Ensure compliance with all relevant regulatory agencies and oversee study data integrity.
• Implement and maintain periodic quality control procedures.
• Interface with departments to obtain UCSF approval prior to study initiation.
• Maintain all regulatory documents and report study progress to investigators.
• Participate in internal and external audits or reviews of study protocols.
• Perform other duties as assigned.

Department Overview

The Division of Cardiology supports a comprehensive, multi-layered clinical research infrastructure with 100-120 active clinical trials covering phase I-IV and post-approval studies. The research portfolio includes pharmaceutical, device, preventative, and social behavioral trials across sub-specialties such as:

• 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 fellows. It comprises 90 full-time faculty, 36 clinical fellows, post-doctoral research fellows, and approximately 60 research support and administrative staff, with annual expenditures exceeding $22 million.

Requirements

• High school graduate with sufficient experience and demonstrated skills to perform assigned duties; equivalent experience/training may substitute.
• Attention to detail and strong interpersonal skills.
• Excellent verbal and written communication skills for coordinating with subjects, team members, departments, and outside institutions.
• Ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work independently, complete projects timely, and prioritize multiple tasks to meet deadlines.
• Demonstrated tact and discretion in handling sensitive communications and confidential information.
• Willingness to travel occasionally for investigator meetings.

Qualifications

• Experience in clinical cardiology and clinical/cardiovascular research (preferred).
• Science, research, or medical background (preferred).
• Applied knowledge in drug and/or device trials (preferred).
• A two-year commitment is preferred.
• Proficiency in the use of the Committee of Human Research (CHR) online iMEDris system for protocol submissions, renewals, and modifications.
• Understanding of patient population dynamics to build rapport and assess realistic participation.
• In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs (preferred).
• Experience building strong working relationships with sponsors, monitors, PIs, and other key stakeholders (preferred).
• Experience with electronic medical records, preferably EPIC.
• Knowledge of biospecimen collection, processing, and transport (preferred).
• Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, HIPAA, and patient safety.
• Familiarity with medical terminology, research policies, and data management tools such as Access, Stata, SAS/SPSS, and Teleform.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals (preferred).
• Experience applying regulations and guidelines including Good Clinical Practice, HIPAA, Protection of Human Research Subjects, CHR recruitment/consent regulations, cash handling procedures, and environmental health/safety training.

Benefits

To learn more about the benefits of working at UCSF, including total compensation, please visit: UCnet Benefits.