Clinical Research Coordinator - Cardiology

• 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 Clinical Research Coordinator (CRC) 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. CRC 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. 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 adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments Help schedule staff time and coordinate staff schedules. Maintain subject tracking systems. Arrange the exchange of and transport of specimens with collaborating Investigators and staff. Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications. Ensure integrity and security of samples. 5 YES Quality control procedures 5 YES Study Implementation 5 YES Specimen Management/ Maintenance 5 YES Regulatory responsibilities Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow-up on CHR submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments. Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. 100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Day shift Required Qualifications High School Diploma; or equivalent experience/training Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines Demonstrated ability to exercise tact and discretion in sensitive communications with patients and others.

Demonstrated ability in handling a variety of confidential information appropriately. Demonstrated positive interpersonal skills and problem solving abilities Willing to travel (limited travel for investigator meetings)

Two-year commitment Experience in clinical cardiology and clinical/cardiovascular research Science, research, or medical background Applied knowledge in drug and/or device trials Proficiency in the use of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system Understanding of patient population to create rapport, while also giving insight to what is realistic and appropriate for patient participation 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 Knowledge of biospecimen collection, processing, and transport Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: 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 the following regulations and guidelines: Good Clinical Practice Guidelines Health Information and Accountability Act (HIPAA) The Protection of Human Research Subjects CHR regulations for recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Health and Safety Training Fire/ Life Safety Training