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Clinical Trials Coordinator
2 months ago
The Clinical Trials Coordinator has primary responsibility for managing clinical trials for the Clinical Trials Office of the WellStar Health System. This includes responsibility for identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating, and following patients in clinical trials; coordinating therapy initiation and continuation; taking call for issues related to clinical trials; completing and filing necessary forms with internal and external departments and agencies as necessary; and maintaining records for patients enrolled in clinical trials.
Core Responsibilities and Essential Functions- Coordinates all facets of patient involvement in clinical trials
- Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines
- Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines
- Communicates with physician/office staff regarding scheduling protocol specific requirements
- Attends patient visits and gathers protocol-specific information when required
- Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate
- Coordinates dispersement of protocol provided drug therapy
- Ensures that Investigation Product chain-of-custody practices are instituted and documented
- Maintains accurate records for patients enrolled on clinical trials
- Communicates effectively with Research Assistants and other research staff
- Gathers appropriate source documentation
- Submits required documentation within designated time frame
- Provides proper documentation of eligibility, treatment and follow-up requirements
- Provides accurate research information to physicians and sponsors
- Maintains a current chart on each protocol patient
- Enters patient visits into clinical trial database
- Ensures regulatory guidelines are followed
- Prepares research charts for monitoring visits and audits and assists with visits as required
- Follows guidelines and timelines for reporting Adverse Events and Deviations
- Maintains current protocol with revisions, amendments and current IRB approved informed consent
- Ensures clinical trial and sponsor-required training is completed
- Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required
- Ensures that ongoing training during the course of a clinical trial is completed
- Facilitates ongoing training for other team members, including investigators
- Maintains current Human Research Participant Protection and Hazardous Material training
- Assists with other departmental functions
- Attends committee meetings as required
- Attends functional team meetings and disseminates information
- Assists with regulatory and billing functions, when required
