Clinical Research Program Coordinator - Core-Ctr For Research Excel
About The Position
Provides daily departmental administrative guidance and reports for new research and sponsored projects. Coordinates clinical research studies and projects, including collaborating on new protocols; reviewing budgetary documents, institutional study agreements, and sponsor indemnification agreements; and ensuring final hospital and Institutional Review Board (IRB) approval. Prepares and presents studies for feasibility review, makes recommendations, and ensures documents are in concordance for study feasibility. Educates nurse managers and clinical nurses about new studies and coordinates site start-up activities. Develops and maintains systems to process and track protocol-related paperwork. Maintains up-to-date status reports and prepares summaries as requested for the supervisor, principal investigator (PI), and/or management staff. Reviews protocols, amendments, and ancillary documents for discrepancies or lack of clarity, working with the PI and/or sponsor to resolve issues. Prepares and submits reports to sponsors, investigators, regulatory authorities, the manager, and others as needed. Collaborates with departments across the organization 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 collaboration on new protocols.
- Review budgetary documents, institutional study agreements, and sponsor indemnification agreements.
- Ensure final hospital and 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 processing and tracking systems for protocol-related paperwork.
- Maintain up-to-date status reports and prepare summary reports as requested for the supervisor, PI, and/or management staff.
- 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 others as needed.
- Collaborate with departments to support clinical trial goals.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
