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Clinical Research Coordinator
2 months ago
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at Atrium Health. The successful candidate will assist with the coordination of clinical, regulatory, business, and other research-related activities and documentation for clinical trials conducted by the Levine Cancer Institute.
Key Responsibilities- Assist with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
- Participate in study project start-up activity, working with the PI and others to initiate new research projects.
- Maintain protocol amendments, deviations, and informed consent changes regarding oncology research studies, ensuring all documentation is managed compliantly and maintained in an audit-ready manner.
- Maintain appropriate documentation, including FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc., for assigned studies.
- Assist in maintenance of filing systems, data repositories, and systems.
- Assist in monitoring clinical trial compliance by reporting issues and problems appropriately.
- Obtain required documentation (forms, slides, reports, etc.) to assess patient eligibility for research studies.
- Contact local research staff to confirm scheduling of tests/treatments required by protocol.
- Obtain and complete data for patients enrolled on clinical trials.
- Complete Case Report Forms (CRFs) with high accuracy.
- Complete/resolve queries from sponsors.
- Obtain required forms, slides, reports, and other information needed to assess patient eligibility.
- Prepare and submit information from patient's chart and other source documents on appropriate data forms/flowsheets/databases.
- Assist with inventory, ordering, organization, and distribution of supplies related to assigned trials.
- Maintain supply inventory with critical focus on expiry management.
- Maintain regulatory binder for review at monitoring visits.
- Maintain patient shadow charts with appropriate source documentation.
- Complete registration for patient enrollment and maintain status in sponsor and LCI databases.
- Assist with coordination of research monitor visits and audits; prepare appropriate data.
- Assist in collection, preparation, and shipping of samples.
- Assist with coordination of required protocol-related activities such as tests and treatments using CTMS.
- Assist in writing/updating Informed Consents with PI and team.
- Support clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, postings, etc.
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. CPR certification required. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.