Clinical Research Coordinator

Overview

The Department of Medicine, Division of Cardiology has developed a clinical research infrastructure within the Division. The goals are to increase industry-sponsored research, create a system that will assist a physician within the division to operationalize an investigator-initiated study, and to develop a general cardiology cohort study. The purpose of this position is to carry out the needed tasks as a part of ongoing and future clinical and translational research projects in the Division of Cardiology.

Job code and details: MED-CORE-CARD, Full Time, 87501 .

• Under the supervision of the Clinical Research Supervisor or Manager, perform duties related to the support and coordination of clinical studies. May receive training and development to advance within the series.
• Support the management of and coordinate the tasks 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 and reports.
• Help coordinate staff work schedules to ensure proper coverage; assist with training of Assistant CRCs and with oversight of other research staff.
• Manage PI’s protocols in the Committee on Human Research online system, renewals and modifications of protocol applications, and the implementation of new studies.
• Participate in the review and writing of protocols to ensure IRB approval and University compliance; help assure compliance with relevant regulatory agencies.
• Oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation.
• Maintain regulatory documents; report study progress to investigators; participate in internal and external audits or reviews of study protocols; perform other duties as assigned.

• Required
• HS graduate with sufficient experience and demonstrated skills to perform the assigned duties and responsibilities.
• Attention to detail; strong interpersonal and written/verbal communication skills to coordinate with subjects, team members, other departments, and outside institutions; ability to multi-task in a fast-paced environment with diverse subject population.
• Ability to work independently, complete projects in a timely manner, and prioritize multiple projects to meet deadlines.
• Tact and discretion in sensitive communications with patients; ability to handle confidential information appropriately.
• Positive interpersonal skills and problem-solving abilities.
• Willing to travel (limited travel for investigator meetings).

• Preferred
• Experience in clinical cardiology and clinical/cardiovascular research.
• Science, research, or medical background; knowledge of drug and/or device trials.
• A two-year commitment is preferred.
• Proficiency in CHR online iMEDris system for protocol submissions, renewals, and modifications.
• Understanding of patient populations to build rapport while providing realistic participation guidance.
• In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs.
• Experience building strong working relationships with Sponsors, Monitors, PIs, and key stakeholders.
• Experience with electronic medical records; EPIC preferred.
• Knowledge of biospecimen collection, processing, and transport.
• Familiarity with UCSF and departmental policies on reimbursement, research guidelines, confidentiality, and HIPAA regulations; understanding of safety and confidentiality policies; knowledge of medical terminology, data management in software tools (e.g., Access, Stata, SPSS), and data collection/analysis platforms.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
• Understanding and application of regulations/guidelines including Good Clinical Practice, HIPAA, Protection of Human Subjects, CHR recruitment/consent, cash handling procedures, Environmental Health and Safety training, and Fire/Life Safety Training.

The University of California, San Francisco (UCSF) is a leading…