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Clinical Research Coordinator
2 months ago
The Clinical Research Coordinator will be responsible for managing clinical trials for the Clinical Trials Office of the WellStar Health System. This includes identifying potential study patients, ascertaining patient eligibility, coordinating and evaluating patients in clinical trials, and maintaining records for patients enrolled in clinical trials.
Key Responsibilities- Coordinate all facets of patient involvement in clinical trials, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.
- Review patient charts for eligibility requirements and enroll patients according to protocol guidelines.
- Communicate with physician/office staff regarding scheduling protocol-specific requirements.
- Attend patient visits and gather protocol-specific information when required.
- Communicate drug doses, protocol requirements, and modifications to physician and office staff as appropriate.
- Coordinate the distribution of protocol-provided drug therapy.
- Ensure that Investigation Product chain-of-custody practices are instituted and documented.
- Maintain accurate records for patients enrolled on clinical trials.
- Communicate effectively with Research Assistants and other research staff.
- Gather appropriate source documentation.
- Submit required documentation within designated time frames.
- Provide proper documentation of eligibility, treatment, and follow-up requirements.
- Provide accurate research information to physicians and sponsors.
- Maintain current charts on each protocol patient.
- Enter patient visits into clinical trial databases.
- Ensure regulatory guidelines are followed.
- Prepare research charts for monitoring visits and audits, and assist with visits as required.
- Follow guidelines and timelines for reporting Adverse Events and Deviations.
- Maintain current protocols with revisions, amendments, and current IRB-approved informed consent.
- Ensure clinical trial and sponsor-required training is completed.
- Facilitate ongoing training for other team members, including investigators.
- Maintain current Human Research Participant Protection and Hazardous Material training.
- Assist with other departmental functions, including attending committee meetings and disseminating information.
- Responsible for additional projects, as directed by the manager.
- Graduate from an approved school of nursing.
- Required and preferred Bachelor's Degree (BSN).
- Required Minimum License(s) and Certification(s): Reg Nurse (Single State) or RN - Multi-state Compact.
- Additional License(s) and Certification(s): None specified.
- Required Minimum Experience: Minimum 5 years RN experience required and minimum 2 years research experience.
- Required Minimum Skills: Strong computer skills, good oral and written communication skills, excellent interpersonal and organization skills.
