Clinical Research Coordinator

University of California, San Francisco•San Francisco, CA

25d

About The Position

The Clinical Research Coordinator performs independently or with general direction at the fully operational journey level. Under the direction of the Clinical Research Supervisor and/or Principal Investigator (PI), the coordinator executes, manages, and coordinates research protocols and the data collection and operations of several concurrent clinical research studies, following research protocols and UCSF and regulating-agency policies. The role coordinates study activities, subject recruitment and retention, study visits, data and specimen management, databases and reports, staff schedules and training, and protocol submissions and adherence. The coordinator helps maintain data integrity and quality-control procedures, assures regulatory compliance, maintains study and regulatory documentation, reports progress to investigators, and participates in audits and reviews. Duties may vary according to the size and complexity of the studies and may include other duties assigned by the PI.

Requirements

High school graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
Attention to detail.
Strong interpersonal skills.
Excellent and effective verbal and written communication skills for coordinating with subjects, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse subject population.
Ability to work independently, complete projects in a timely manner, and prioritize multiple projects to meet deadlines.

Responsibilities

Identify, recruit, screen, and enroll study subjects; develop recruitment and retention strategies.
Schedule and conduct study visits; administer questionnaires, collect medical histories, and perform study procedures.
Maintain effective communication and rapport with subjects, address their needs, schedule follow-up visits, 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 resolve related discrepancies and issues.
Coordinate staff and study procedures to ensure specimens are properly stored, required data are collected, and shipping and labeling requirements are met.
Coordinate scheduling and communication with other studies, technicians, affiliated groups, and collaborating staff.
Review medical charts and electronic records to extract study information and data.
Recommend improvements to patient coordination, data collection and management, protocol adherence, and study collaboration.
Collect and enter data from subject visits, procedures, lab tests, and other study participation into databases in a timely manner.
Manage and improve 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.
Train staff and others on protocols, procedures, data collection and entry, databases, medical chart review, and storage.
Attend and participate in regular team meetings; assess policies and procedures related to recruitment, data collection, and management; and help ensure consistency in data collection and entry.
Maintain procedure manuals, subject tracking systems, and periodic quality-control procedures; suggest modifications to administrative infrastructure and data collection instruments as needed.
Help schedule staff time and coordinate staff schedules.
Arrange the exchange and transport of specimens; oversee incoming sample data and ensure it is used appropriately for analysis and publications; protect sample integrity and security.
Enter and maintain study protocols in the Committee on Human Research (CHR) online system; coordinate with CHR Analysts and serve as a liaison between CHR and study investigators.
Review and write protocols and related procedures; renew, modify, and submit CHR applications in a timely manner; assess whether protocols or applications require changes and implement improvements.
Design and enhance case report forms and data collection forms as needed, and provide manuscript feedback.
Ensure studies follow the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations; track CHR submission and approval status and obtain UCSF approvals before study initiation.
Maintain regulatory documents, monitor data-submission timelines, and document and report adverse events to appropriate departments.
Protect patient confidentiality when communicating with agencies, healthcare providers, other studies, and departments.
Participate in and cooperate with internal and external audits or reviews of study protocols and prepare required documentation.
Perform other duties as assigned by the PI.