Clinical Research Coordinator

About This Role

This role supports clinical and translational research projects within the Division of Cardiology, managing studies, coordinating tasks, and ensuring regulatory compliance to advance the division's research mission.

Responsibilities

• Manage and coordinate single or multiple clinical research studies
• Act as intermediary between services and departments, overseeing data and specimen management
• Manage and report on study results
• Create, update, and manage databases, comprehensive datasets, and reports
• Help coordinate staff work schedules to ensure proper coverage
• Assist with training of Assistant CRCs and provide oversight to other research staff
• Manage PI’s protocols in the Committee on Human Research online system, including renewals and modifications
• Participate in the review and writing of protocols to ensure institutional review board approval and University compliance
• Help assure compliance with all relevant regulatory agencies
• Oversee study data integrity and implement periodic quality control procedures
• Maintain all regulatory documents and report study progress to investigators
• Participate in internal and external audits or reviews of study protocols

Requirements

• Attention to detail
• Strong interpersonal skills
• Excellent, effective verbal and written communication skills
• Ability to multi-task in a fast-paced environment
• Ability to work well independently
• Ability to complete projects in a timely manner
• Ability to prioritize multiple projects
• Demonstrated ability to exercise tact and discretion in sensitive communications
• Demonstrated ability in handling a variety of confidential information appropriately
• Demonstrated positive interpersonal skills and problem solving abilities
• Willingness to travel (limited travel for investigator meetings)

Qualifications

• HS graduate and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities

Nice to Have

• Experience in clinical cardiology and clinical/cardiovascular research
• Science, research, or medical background
• Applied knowledge in drug and/or device trials
• A two-year commitment is preferred
• Proficiency in the use of Committee of Human Research (CHR) online iMEDris system
• Understanding of patient population to create rapport and assess patient participation realism
• In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs
• Experience in building strong working relationships with Sponsors, Monitors, PIs, and other key stakeholders
• Experience with electronic medical records (EPIC preferred)
• Knowledge of biospecimen collection, processing, and transport
• Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, and HIPAA regulations
• Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances
• Experience with database building/analysis and data management within Access, Stata, SASS/SPSS, and Teleform programming platforms
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience applying Good Clinical Practice Guidelines
• Experience applying Health Information and Accountability Act (HIPAA)
• Experience applying The Protection of Human Research Subjects
• Experience applying CHR regulations for recruitment and consent of research subjects
• Experience applying Effective Cash Handling Procedures
• Experience applying Environmental Health and Safety Training
• Experience applying Fire/Life Safety Training

Skills

* Required skills