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Job Description
- Req#: 12073
- Oversees operational issues necessary to ensure timely and accurate submission by Institutional Review Board (IRB). Reviews all applications and protocols submitted to the IRB to determine consistency with federal guidelines. Ensures all documentation is consistent with federal and institutional guidelines.
- Provides guidance and consultation to IRB members and investigators regarding implementation of regulations and policies and procedures concerning human research.
- Coordinates correspondence between investigators, IRB and federal agencies pertinent to research using human subjects.
- Maintains organized files and regularly audits IRB records and files.
- Disseminates updated standard operating procedures to investigators and research coordinators to ensure compliance with federal and institutional guidelines.
- Trains and advises investigators, research coordinators and other research staff on the preparation of IRB submissions and federal guidelines.
- Assists Chair of MSH Institutional Review Board as needed in review of accusations of scientific misconduct and dissemination of material regarding federal regulations and policy regarding scientific misconduct
- Composes routine and non-routine correspondence.
- Maintains IRB submission database.
- Establishes files for new IRB submissions.
- Assists in compliance educations sessions; assists in ongoing development of educational material regarding IRB regulations and standards.
- Provides support to facilitate research at Sinai Health System as needed.
- Assists in preparing educational materials for presentation.
- Responds to data requests and queries if any from the office of business integrity. Ensures compliance with privacy and health information standards.
- Prepares the IRB materials for distribution at meetings.
- Assists in the coordination of educational sessions facilitated by the IRB
- Prepares monthly progress reports (or as needed) for the Institutional Review Board
- Performs other related duties as assigned.
- BACHELOR’S DEGREE OR 4 YEARS OF RESEARCH RELATED EXPERIENCE.
- 4 YEARS OF RESEARCH RELATED EXPERIENCE IN AN ADMINISTRATIVE OR PLANNING ROLE.
- ADVANCED COMPUTER SKILLS (WORD, ACCESS, EXCEL).
- ADVANCED ORGANIZATIONAL AND PLANNING SKILLS.
SINAI HEALTH SYSTEM RESEARCH IRB COORDINATOR
Responsible for supporting the performance of the SHS-IRB regarding human subjects research; reviews all protocols submitted to the IRB for any proposed research to determine consistency with federal regulations and institutional guidelines; coordinates and manages the operations of the IRB Office and information system, and performs other related duties as assigned.
WHAT YOU WILL DO:
WHAT YOU WILL NEED:
REQUIRED LICENSES, CERTIFICATES, REGISTRATIONS:
CERTIFICATION IN CLINICAL RESEARCH THROUGH AND ACCREDITED RESEARCH PROFESSIONAL ORGANIZATION
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