Clinical Research Program Coordinator - Core-Ctr For Research Excel
About The Position
Provides daily departmental administrative guidance and reports for conduct of new research and new sponsored projects; responsible for coordinating clinical research studies or projects which includes collaboration of new protocols, review of budgetary documents, review of institutional study agreements and indemnification agreements with study sponsors, ensuring final hospital and Institutional Review Board (IRB) approval for research studies, preparation, presentation and make recommendation for feasibility review of studies and ensure all documents are in concordance for study feasibility. Educates nurse managers/clinical nurses in reference to new studies. Coordinates activities associated with site start-up. Develops and maintains a processing and tracking systems for protocol related paperwork. Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff. Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or Sponsor to resolve. Prepares and submits various reports to sponsors, investigators, regulatory authorities, and Manager and any others deemed necessary. Collaboratively works with all departments to provide support for clinical trials goals.
Requirements
- Bachelors Degree in Administration or other related field
- 3 years experience in research administration, clinical research, or project management
- Independent working knowledge of Clinical trial management system
- Independent working knowledge of electronic health record
- Independent working knowledge of spreadsheet software
- Independent working knowledge of database software
Responsibilities
- Provides daily departmental administrative guidance and reports for conduct of new research and new sponsored projects.
- Coordinates clinical research studies or projects.
- Collaborates on new protocols.
- Reviews budgetary documents.
- Reviews institutional study agreements and indemnification agreements with study sponsors.
- Ensures final hospital and Institutional Review Board (IRB) approval for research studies.
- Prepares, presents, and makes recommendations for feasibility review of studies.
- Ensures all documents are in concordance for study feasibility.
- Educates nurse managers/clinical nurses in reference to new studies.
- Coordinates activities associated with site start-up.
- Develops and maintains processing and tracking systems for protocol-related paperwork.
- Maintains up-to-date status reports and creates summary reports as requested for supervisor, PI, and/or management staff.
- Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity.
- Works with PI and/or Sponsor to resolve discrepancies.
- Prepares and submits various reports to sponsors, investigators, regulatory authorities, and Manager and any others deemed necessary.
- Collaboratively works with all departments to provide support for clinical trials goals.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
