Clinical Research Coordinator - Cardiology

UCSF•San Francisco, CA

12d•$40 - $65

About The Position

The Department of Medicine, Division of Cardiology is building and expanding clinical research infrastructure to support industry-sponsored research, investigator-initiated studies, and a general cardiology cohort study. The Clinical Research Coordinator (CRC) carries out tasks for ongoing and future clinical and translational research projects in the Division. Under the supervision of the Clinical Research Supervisor, the CRC supports and coordinates clinical studies and may receive training and development to advance to the next level within the series. The Cardiology Clinical Research Unit supports 100–120 active clinical trials, including Phase I–IV and post-approval studies across pharmaceutical, device, preventive, and social-behavioral research. The Division includes multiple cardiology subspecialty sections and conducts clinical practices, basic and clinical research, and medical education. It has 90 full-time faculty, approximately 60 research support and administrative staff, and other academic and clinical personnel. The Division spends over $22 million annually on its clinical, research, training, and service missions and operates primarily across the Parnassus and Mission Bay campuses, with clinical fellows also rotating at Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center. The CRC may coordinate one or more studies according to their size and complexity; work with research participants, clinical teams, investigators, departments, and external collaborators; manage data, specimens, databases, and study reports; support protocol submissions and regulatory compliance; and help train staff and coordinate work schedules. The role also supports study quality, data integrity, patient safety, and confidentiality.

Requirements

High school diploma or equivalent experience or training.
Attention to detail; strong interpersonal skills; and excellent verbal and written communication skills for coordination with participants, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse participant population.
Ability to work independently, complete projects on time, and prioritize multiple projects to meet deadlines.
Tact and discretion in sensitive communications and appropriate handling of confidential information.
Positive interpersonal skills and problem-solving abilities.
Willingness to travel for investigator meetings; travel is limited.

Nice To Haves

Two-year commitment.
Experience in clinical cardiology and clinical or cardiovascular research.
Science, research, or medical background.
Applied knowledge of drug and/or device trials.
Proficiency with the CHR online iMEDris system for protocol submission, renewal, and modification.
Understanding of the participant population and ability to build rapport while assessing what is realistic and appropriate for participant involvement.
In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs.
Experience building working relationships with sponsors, monitors, principal investigators, and other stakeholders.
Experience with electronic medical records, including EPIC.
Knowledge of biospecimen collection, processing, and transport.
Knowledge of UCSF and departmental policies for reimbursement, research, confidentiality, and HIPAA; the UCSF research mission; patient safety and confidentiality procedures; medical terminology; research policies and guidelines; and infectious-substance packaging and shipping guidelines.
Knowledge of database building, analysis, and data management using some of Access, Stata, SAS/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; HIPAA; protections for human research subjects; CHR recruitment and consent regulations; effective cash-handling procedures; Environmental Health and Safety Training; and Fire/Life Safety Training.

Responsibilities

Identify, screen, recruit, and enroll study participants; develop recruitment and retention strategies.
Schedule study visits, administer questionnaires, collect medical histories, and perform study procedures.
Maintain communication and rapport with participants, support retention and follow-up, and coordinate continuity of care with providers.
Obtain informed consent, review study information with participants, and advocate for participant safety throughout protocol procedures.
Oversee participant reimbursement and help resolve discrepancies or issues.
Coordinate study procedures, specimen storage, data collection, shipping, and labeling with staff and affiliated groups.
Review medical charts and electronic records to extract study information and data.
Assess and recommend improvements to participant coordination, data collection and management, protocol adherence, and study collaboration.
Collect and enter data from visits, procedures, laboratory tests, and other study participation into databases in a timely manner.
Manage and improve study database structures, create databases as needed, maintain comprehensive datasets and data collection forms, and perform database queries and analyses.
Work with the supervisor to maintain complete and accurate study data and analyze data as it becomes available.
Enter and maintain study protocols in the Committee on Human Research (CHR) online system; coordinate with CHR analysts and investigators.
Review and write protocols and related procedures, renew and modify CHR applications, submit protocols on time, and serve as a liaison between CHR and investigators.
Design and improve case report forms and data collection forms; provide manuscript feedback and maintain systems for protocol adherence and data quality.
Conduct quality assurance checks, evaluate protocols, and implement improvements as needed.
Enter active studies in OnCore, maintain patient visit status, and coordinate with the Research Financial Analyst to ensure activities are entered and invoiced appropriately.
Train staff on protocols, procedural changes, data collection and entry, database procedures, chart review, and storage.
Participate in team meetings; oversee data integrity and assess policies and procedures for recruitment, data collection, and data management.
Maintain procedure manuals and subject-tracking systems, support consistent data collection and entry, and implement periodic quality-control procedures.
Help schedule and coordinate staff time; suggest administrative infrastructure changes to accommodate more complex studies.
Coordinate specimen exchange and transport, oversee data derived from samples, and ensure sample integrity and security.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Track CHR submissions, modifications, and approval status; obtain UCSF approvals before study initiation.
Maintain regulatory documents, monitor data-submission timelines, document adverse events, and submit them to appropriate departments.
Protect patient confidentiality when communicating with agencies, providers, study teams, and outside departments.
Participate in internal and external audits or protocol reviews and prepare required documentation.
Perform other duties as assigned.
Travel for investigator meetings as needed; travel is described as limited.