Clinical Research Coordinator Cardiology

Description 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. Under the supervision of the Clinical Research Supervisor, the incumbent will perform duties related to the support and coordination of clinical studies, and may receive training and development to prepare and advance to the next level within the series. Incumbent’s duties may include, but will not be limited to, support the management of and coordinate the tasks of single or multiple clinical research studies, depending on their 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 to coordinate staff work schedules to ensure proper coverage; assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage PI’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; 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; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. Department Overview: Overview The Department of Medicine, Division of Cardiology has established a comprehensive, multi-layered clinical research infrastructure to support and expand the Division’s research mission. This infrastructure supports industry-sponsored research, facilitates investigator-initiated studies, and advances a general cardiology cohort study, while offering clear opportunities for professional growth in clinical research operations and leadership. The Cardiology Clinical Research Unit (CCRU) supports 100-120 active clinical trials. The CCRU research portfolio covers phase I- IV and post approval trial types and covers a diversity of trials ranging from pharmaceutical, device, preventative, and social behavioral research. Within the Division are sub-specialty sections for: 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; and Prevention. The Division runs several clinical practices in multiple sites, conducts basic and clinical research, and educates medical students, residents, clinical fellows through ACGME as well as non-ACGME training programs. In addition, the Division has significant and complex financial and administrative relationships with the Department of Medicine (DOM) and the UCSF Medical Center, as well as large patient care programs in the sections noted above, large clinical, Federal, and privately supported research programs and six faculty laboratories. The Division has 90 full-time faculty, several non-faculty academics, 36 clinical fellows, several post-doctoral research fellows, and approximately 60 research support and administrative staff. The Division currently expends over $22 million per year in pursuit of its clinical, research, training, and service missions. While the Division is primarily split between the Parnassus and Mission Bay campuses, clinical fellows have rotations at the Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center. Responsibilities % of time Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 30 YES Study Coordination and Data Collection • Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. • Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures. • Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care. • Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. • Oversee subject reimbursement; work to resolve discrepancies and issues. • Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures. • Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups. • Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. • Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration. 30 YES Data management and reporting of results • Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner. • Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. • Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI. • Maintain data collection forms for effective data collection, entry, and analysis. • Perform queries and analysis in databases. • Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available. 15 YES Protocol Submissions and Adherence • Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts. • Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality. • Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. • Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators. • Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed. • Enter all active studies in OnCore and maintain patient visit status. Work closely with the Research Financial Analyst to ensure all study activities have been entered and invoiced appropriately. 5 YES Staff training • Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures. • Attend and actively participate in regular team meetings • Oversee data integrity; initiate assessments of the a