Overview

Job Summary

Assists with the coordination of clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidances, GCP and ICH.

Essential Functions

• Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
• Participates in the study project start-up activity, working with the PI and others to initiate new research projects.
• Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assuring all documentation is managed compliantly and maintained in an audit-ready manner.
• Maintains appropriate documentation, (i.e. FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc.) for assigned studies.
• Assists in maintenance of filing systems, data repositories and systems.
• Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
• Obtains required documentation (forms, slides, reports, etc.) to assess patient eligibility for research studies.
• Contacts local research staff to confirm scheduling of tests/treatments required by protocol.
• Obtains and completes data for patients enrolled on clinical trial.
• Completes Case Report Forms (CRFs) maintaining high level of accuracy.
• Completes/resolves queries from sponsors.
• Obtains required forms, slides, reports, and other information needed to assess patient eligibility.
• Prepares and submits information from patient's chart and other source documents on appropriate data forms/flowsheets/databases.
• Assists with inventory, ordering, organization and distribution of supplies related to assigned trials.
• Maintains supply inventory with critical focus on expiry management.
• Maintains regulatory binder for review at monitoring visits.
• Maintains patient shadow charts with appropriate source documentation.
• Completes registration for patient enrollment and maintains status in sponsor and LCI databases.
• Assists with the coordination of research monitor visits and audits; prepares appropriate data.
• Assists in the collection, preparation and shipping of samples.
• Assists with the coordination of required protocol-related activities such as tests and treatments using CTMS.
• Assists in writing/updating Informed Consents with PI and team.
• Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, ClinicalTrials.gov postings, etc.

Physical Requirements

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.

Education, Experience and Certifications

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.