Clinical Research Program Coordinator - Core-Ctr For Research Excel
About The Position
Provides daily departmental administrative guidance and reports for the conduct of new research and sponsored projects. Coordinates clinical research studies and projects, including protocol collaboration, review of budgetary and institutional study documents, obtaining hospital and Institutional Review Board (IRB) approvals, and preparing and presenting studies for feasibility review. Ensures documents are in concordance for study feasibility and educates nurse managers and clinical nurses about new studies. Coordinates site start-up activities, develops and maintains systems for processing and tracking protocol-related paperwork, maintains current status reports, and prepares summary reports as requested. Reviews protocols, amendments, and ancillary documents for discrepancies or lack of clarity and works with the principal investigator (PI) and/or sponsor to resolve them. Prepares and submits reports to sponsors, investigators, regulatory authorities, the manager, and other necessary parties. Works collaboratively across departments to support clinical trial goals.
Requirements
- Bachelor’s degree in administration, business, or a related field.
- Three years of experience in research administration, clinical research, or project management.
- Independent working knowledge of a clinical trial management system, electronic health record, spreadsheet software, and database software.
Responsibilities
- Provide daily departmental administrative guidance and reports for new research and sponsored projects.
- Coordinate clinical research studies and projects, including protocol collaboration and review of budgetary documents, institutional study agreements, and indemnification agreements.
- Ensure final hospital and Institutional Review Board (IRB) approval for research studies.
- Prepare and present studies for feasibility review, make recommendations, and ensure documents are in concordance for study feasibility.
- Educate nurse managers and clinical nurses about new studies.
- Coordinate activities associated with site start-up.
- Develop and maintain systems for processing and tracking protocol-related paperwork.
- Maintain up-to-date status reports and create summary reports for the supervisor, PI, and/or management staff as requested.
- Review protocols, amendments, and ancillary documents for discrepancies or lack of clarity, and work with the PI and/or sponsor to resolve issues.
- Prepare and submit reports to sponsors, investigators, regulatory authorities, the manager, and other necessary parties.
- Collaborate with departments to support clinical trial goals.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
