Research Nurse Specialist
6 days ago
Atrium Health is seeking a highly skilled Clinical Research Coordinator to join our team. As a key member of our research team, you will be responsible for coordinating clinical, regulatory, business, and other research-related activities and documentation for clinical trials conducted by the Levine Cancer Institute.
Key Responsibilities- Study Coordination: Assist with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
- Project Start-up: Participate in the study project start-up activity, working with the PI and others to initiate new research projects.
- Protocol Management: Maintain protocol amendments, deviations, and informed consent changes regarding oncology research studies, assuring all documentation is managed compliantly and maintained in an audit-ready manner.
- Documentation Management: Maintain appropriate documentation, (i.e. FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc.) for assigned studies.
- Data Management: Assist in maintenance of filing systems, data repositories and systems.
- Compliance Monitoring: Assist in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
- Patient Eligibility: Obtain required documentation (forms, slides, reports, etc.) to assess patient eligibility for research studies.
- Research Staff Coordination: Contact local research staff to confirm scheduling of tests/treatments required by protocol.
- Data Collection: Obtain and complete data for patients enrolled on clinical trial.
- Query Resolution: Complete/resolves queries from sponsors.
- Supply Management: Assist with inventory, ordering, organization and distribution of supplies related to assigned trials.
- Regulatory Binder Maintenance: Maintain regulatory binder for review at monitoring visits.
- Shadow Charts: Maintain patient shadow charts with appropriate source documentation.
- Database Management: Complete registration for patient enrollment and maintains status in sponsor and LCI databases.
- Research Monitor Visits: Assist with the coordination of research monitor visits and audits; prepares appropriate data.
- Sample Collection: Assist in the collection, preparation and shipping of samples.
- Protocol-related Activities: Assist with the coordination of required protocol-related activities such as tests and treatments using CTMS.
- Informed Consent: Assist in writing/updating Informed Consents with PI and team.
- Team Support: Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, postings, etc.
- Education: Must hold a valid North Carolina or South Carolina (as applicable) Board of Nursing license. Graduate of an accredited nursing program (ADN, RN) required. Bachelor's Degree in Nursing (BSN), or higher, preferred.
- Experience: Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
- Certifications: CPR certification required.
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