Clinical Research Coordinator III

Classification Title:

Clinical Research Coordinator III

Job Description: The Clinical Research Coordinator III will coordinate research projects for the Department of
Anesthesiology. This position will involve execution of all components of research studies under the
direction of the principal investigator and/or supervisor. The coordinator plays an active, expert level role in
managing the day-to-day activities of assigned research studies. Expected to possess effective
problem-solving skills, the ability to multi-task as part of a team or independently, and to communicate
effectively with patients, medical staff, and university staff and faculty.   Duties Include: Clinical Research Coordination: Responsible for the coordination of study requirements for assigned research studies. This includes the following tasks:

• Manage the day-to-day activities of the assigned research studies, including problem-solving, communication, and protocol management with the PI.
• Supervise OPS and volunteers involved in assigned studies.
• Support clinical conduct of research and perform these duties as needed.
• Review and develop a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Communicate study requirements to all individuals involved in the study. Provide appropriate training and tools for study team members. Document date of training and signatures of study personnel trained on the study-specific training log.
• Conduct in-services as needed with hospital staff.
• Collect documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Develop and implement recruitment strategies in accordance with IRB requirements and approvals in collaboration with the PI and the study team.
• Conduct or participate in the informed consent process, including interactions with the IRB, discussion with research participants, and answering any questions related to the protocol. Obtain appropriate signatures and dates on forms in appropriate places. Assure that amended consent forms are appropriately implemented and signed.
• Screen subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Register each participant in the Oncore.
• Coordinate participant tests and procedures.
• Administers medications, isolates blood and/or tissue components as directed by protocols as appropriate.
• Examine and assess patients.
• Monitor physical status of the patients, participate in rounds, and select patients for clinical studies.
• Collect data as required by the protocol. Assure timely completion of Case Report Forms.
• Maintain study timelines.
• Maintain adequate inventory of study supplies, including Investigational Drug/Device Accountability.
• Complete study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms etc.
• Retain all study records in accordance with sponsor requirements and University policies and procedures.
• Maintain effective and ongoing communication with the sponsor, research participants, and PI during the course of the study.
• Assist PI in preparation and submission of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Build and work with data within REDCap.

Regulatory and IRB: Responsible for regulatory operations and associated administrative tasks related to assigned research studies:

• Follow the Office of Clinical Research’s (OCR) required initial submission process.
• Complete and send out required OCR documents, including but not limited to cost of service forms (COS), billing grids, device/drug tables, etc.
• Prepare initial submissions, revisions, and continuing reviews to the IRB for submission.
• Prepare serious adverse events and deviation logs after review with the PI for IRB submission.
• Attend all IRB meetings when assigned protocols are scheduled.
• Review and comprehend the protocol and collaborate with the PI and research manager to prepare IRB and any other regulatory submission documents.
• Prepare other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, Form FDA 1572, financial disclosures, and PI licenses as needed.
• Ensure proper organization of study files, including but not limited to, re