Clinical Research Coordinator - Surgery

University of California, San Francisco•San Francisco, CA

About The Position

The Clinical Research Coordinator (CRC) works independently or with general direction to execute, manage, and coordinate clinical research protocols under the direction of the Clinical Research Supervisor and/or Principal Investigator (PI). Depending on study size and complexity, the CRC may coordinate data collection and operations for several concurrent studies while following research protocols and UCSF and regulatory-agency policies. The role coordinates study activities, serves as an intermediary among services and departments, and oversees data and specimen management. It includes managing study results; creating, cleaning, updating, and maintaining databases, datasets, and reports; coordinating staff schedules; assisting with staff training and oversight; and managing protocol applications, renewals, and modifications in the Committee on Human Research (CHR) system. The CRC participates in protocol review and writing, helps ensure institutional review board approval and regulatory compliance, oversees data integrity, maintains quality-control procedures and regulatory documents, reports progress to investigators, and participates in internal and external audits or reviews. The position is in the UCSF Department of Surgery, whose mission includes developing future surgical leaders, providing high-quality and compassionate clinical care, and advancing scientific knowledge and clinical practice through basic and clinical research. The role supports the Division of Transplant, which includes Liver, Kidney, and Pancreas Services and focuses on care for patients with end-stage organ disease and/or transplantation. Study coordination includes identifying, recruiting, screening, and enrolling subjects; scheduling visits; obtaining informed consent; collecting study information and specimens; supporting patient safety and retention; and coordinating follow-up and reimbursement. The CRC enters and manages study data, maintains databases and data collection forms, performs queries and analyses, supports specimen handling and security, and helps train staff. The CRC also submits and maintains CHR protocols, tracks approvals and timelines, maintains regulatory records, documents adverse events, and supports audits.

Requirements

High school diploma, or equivalent experience or training.
Attention to detail.
Strong interpersonal skills.
Excellent and effective verbal and written communication skills.
Ability to multitask in a fast-paced environment while working with a diverse subject population.
Ability to coordinate with subjects, team members, other departments, and outside institutions.
Ability to work independently, complete projects in a timely manner, and prioritize multiple projects to meet deadlines.

Nice To Haves

Fluency using the Committee on Human Research (CHR) online iMEDris system to submit, renew, and modify protocols.
Understanding of the patient population and ability to build rapport and assess realistic and appropriate participation.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Bachelor of Science degree.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies concerning reimbursement, research guidelines, confidentiality and HIPAA, patient safety, and handling electronic and paper medical records and communications.
Knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping guidelines, database building and analysis, and data management using some of Access, Stata, SAS/SPSS, and Teleform programming platforms.
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 Safety training.

Responsibilities

Identify potential subjects; develop recruitment and retention strategies; screen and enroll study participants.
Schedule study visits, administer questionnaires, collect medical histories, and perform study procedures.
Maintain communication and rapport with subjects, respond to their needs, coordinate follow-up, and act as an intermediary; discuss study outcomes with providers to support continuity of care.
Obtain informed consent, review study information with subjects, and advocate for patient safety throughout protocol procedures.
Oversee subject reimbursement and help resolve discrepancies or issues.
Coordinate with staff to ensure procedures are completed, specimens are stored correctly, and required data are collected; ensure proper specimen labeling and shipping.
Coordinate scheduling and communication with other studies, technicians, and affiliated groups.
Review medical charts and electronic records to extract study information.
Assess and recommend improvements to patient coordination, data collection and management, protocol adherence, and collaboration among studies.
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; perform database queries and analyses; and work with the Supervisor to maintain accurate study data.
Help train staff on research protocols, procedures, data collection and entry, databases, medical-chart review, and related processes; participate in team meetings.
Oversee data integrity, assess recruitment and data-management procedures, maintain procedure manuals, support consistency in data collection and entry, and implement quality-control procedures.
Help coordinate staff schedules, maintain subject-tracking systems, and arrange specimen exchange and transport with collaborating investigators and staff.
Oversee incoming data interpreted from samples and ensure appropriate use for analysis and publications; protect sample integrity and security.
Enter new and existing protocols into the CHR online system; renew, modify, and submit CHR applications and protocols; track submissions and approval status; and liaise with CHR and investigators.
Design or improve case report and data-collection forms, provide manuscript feedback, and maintain systems for protocol adherence and data quality.
Participate in reviewing and writing protocols and related procedures to support institutional review board approval and University compliance.
Ensure studies follow the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations; obtain departmental 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, healthcare providers, studies, and outside departments.
Participate in and cooperate with internal and external audits or reviews of study protocols and prepare required documentation.
Assist the Clinical Research Supervisor and/or PI with oversight of research staff and perform other duties as assigned.