Clinical Research Coordinator

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Incumbent’s duties may include, but will not be limited to supporting the management and coordinating 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, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’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 within 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.

% 

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

80%

Yes

Study Coordination and Data Collection

• Responsible for coordinating multiple clinical research studies simultaneously including multicenter clinical trials, NIH and industry-sponsored studies, and local investigator-initiated clinical trials.
• Identify subjects, develop recruitment and retention strategies, obtain informed consent, screen and enroll study subjects; assess and advocate for patient safety throughout each protocol procedure
• Schedule subjects for study visits, study assessment (e.g., labs, imaging) and/or administer other study related assessments such as questionnaires, collect medical history and perform study procedures according to the study protocol.
• 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.
• 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 staff 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.
• Develop and maintain required documentation for clinical trials.
• Reconciliation of subject encounters with billing to ensure correct billing practices and billing compliance to avoid improper billing of Medicare, private insurance, or patients.
• Document study participants’ progress, when applicable, in clinical trials management system, electronic medical record, electronic data capture, sponsor related documents and internal tracking logs/study records as per protocol.
• Assist in the development of databases and participant trackers needed to capture specific protocol required data.
• Develop and enhance case report forms and data collection forms as assigned.
• Provide ongoing study specific training to other staff members to assure patient safety and adherence to the protocol.
• 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 structu