Research Nurse Coordinator (Open Rank)
Exponent · Itesiwaju
Job description
About the role
The Research Nurse Coordinator supports complex clinical research protocols involving investigational drugs, devices, or interventions. Working under the Principal Investigator, the coordinator acts as a liaison among UMMS, clinical partners, the IRB, and sponsors to ensure compliance with Good Clinical Practice (GCP) throughout each study.
Key responsibilities
- Review and abstract medical record information in line with study protocols, institutional policies, and HIPAA requirements.
- Collaborate with investigational pharmacy to follow randomization schemas, dosing, and administration per protocol.
- Screen, enroll, randomize, and obtain consent from patients according to GCP standards.
- Perform nursing assessments, document study events, and maintain confidentiality of patient and sponsor information.
- Identify, triage, report, and document adverse events in accordance with IRB and sponsor guidelines.
- Schedule, perform, and coordinate all study procedures, ensuring regulatory paperwork is complete and accurate.
- Review clinical billing charges for appropriateness and enter study data into the clinical trial management system.
- Participate in internal quality‑assurance audits and attend required training sessions.
Required profile
- Experience conducting clinical research protocols and interacting with IRBs and sponsors.
- Strong knowledge of GCP, HIPAA, and federal/state regulations governing human subjects research.
- Ability to perform nursing assessments and provide clinical consultation as needed.
- Excellent attention to detail for documentation, adverse‑event reporting, and regulatory compliance.
Required skills
- Clinical trial management system (CTMS) usage.
- Electronic medical record abstraction.
- Adverse event identification and reporting.
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Exponent
Itesiwaju
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