Overview
Job Summary
Coordinates clinical, regulatory, business, and other research-related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.
Essential Functions
- Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within department.
- Participates in the study project start-up activity, works with the PI and others to initiate new research projects.
- Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner.
- Maintains appropriate documentation 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 and assesses 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 trials.
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 clinical trials.
Education, Experience and Certifications
High School Diploma or GED required; bachelor's degree preferred, Health/Science preferred. Experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
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