Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Responsible for new research application (including study start-up processes and requirements) and submission of protocols with subsequent amendments. Participates in protocol writing as needed and maintains initial and continuing education for Good Clinical Practice compliance.
Job Specific Duties
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- Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
- Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol.
- Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance.
- Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives.
- Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff.
- Interacts with patients and families to recruit (screen, consent and enroll) study subjects and ensures compliance with the protocol.
- Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies.
- Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format.
- Submits amendments of protocols to Research Regulatory Affairs team and verifies the required corrections were inserted following the established procedures.
- Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.
- Follows NCHS RI’s Standard Operating Procedures, AAHRPP, HIPAA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.
- Enters Research Patient information into CTMS within 72hours of enrollment, patient visit or patient-related event.
- Provides new Protocols, Amendments and study status updates to necessary research staff for digitization/entry into CTMS.
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