Clinical Research Coordinator

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

80%

Yes

• 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 structure for each study protocol; update databases to improve data analysis and management.
• Create and maintain comprehensive data sets as requested by supervisor and/or PI.
• Maintain data collection instruments (e.g. Case Report Forms) for effective data collection, entry, and analysis.
• Maintain subject data and address study specific data queries promptly; perform queries and analysis in databases
• Assure studies are carried out in accordance with all relevant regulations including Code of Federal Regulations, Good Clinical Practice, UCSF regulations, and in accordance with Departmental SOPs
• Initiate and follow-up on CHR submissions and modifications as assigned; track approval status.
• Interface with departments to obtain UCSF approval prior to study initiation.
• Maintain regulatory documents, monitor timelines for data submission.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, sponsors, healthcare providers, other studies and outside departments.
• Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research.
• Monitor participants for evidence of study related adverse events.
• Create/submit IDE application and act as an FDA liaison for investigator led clinical trial
• FDA, CHR, and NIH audit prevention, preparation, execution and follow-up
• Participation in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation
• Document adverse events and protocol deviations and submit to appropriate departments.
• 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.
• 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.
• Assist Principal Investigator in preparing clinical trial protocols and required documentation to the Institutional Review Board, the University, and corporate or government sponsors, as needed.
• Update, maintain and documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Develop and maintain systems for assuring protocol adherence and data quality.
• Create/submit IDE application and act as an FDA liaison for investigator led clinical trial.
• 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;
• Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR within stated timelines
• Maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Responsible for the maintenance and integrity of the patient reported outcomes
• Ensures proper collection, processing, storage, transport, and handling of biological specimens.

Data Management and Reporting

Regulatory

Quality Control

Specimen Management/ Maintenance

15%

Administrative and Communications:

• Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of assigned studies Prepares and presents study materials to members of the interdisciplinary team, PI (s)/Subspecialty Unit regarding general research procedures and study specific elements of a protocol.
• Actively participate in regular team meetings
• Recruitment effort: help develop strategies to ensure increased study awareness and participant enrollment.

10%

Staff Training

• Remain up to date on all required trainings (E.g., UCSF trainings, Departmental trainings, study specific trainings, etc.)
• Serve as a resource for investigators and clinical research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
• May assist in training new staff in preparation and conduct of clinical trials by providing oversight and guidance.

100%

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