Clinical Research Coordinator Cardiology

University of California, San Francisco•San Francisco, CA

2d•Onsite

About The Position

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. 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.

Requirements

HS graduate and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
Attention to detail
Strong interpersonal skills
Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions
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)

Nice To Haves

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 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 preferred.
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

Responsibilities

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.
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.
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.
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.
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.