| Manager - IRB -- Cincinnati, OH |
Author: Jeremy Corsmo
Date: 04-10-08 12:12
Manager IRB
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, OH
OVERVIEW:
The Manager is responsible for the overall administration of the IRB office, which supports the CCHMC Institutional Review Board(IRB) and CCHMC investigators through the regulatory review process.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Support the activities of the Office of Research Compliance and Regulatory Affairs (ORCRA) and the Director (ORCRA).
2. Continually review, update and correct policies and procedures for the IRB as required to assure compliance with applicable federal regulations, AAHRPP Standards, institutional policy and the hospital's Federal Wide Assurance.
3. Administer CCHMC's Federal Wide Assurance and OHRP IRB Registrations.
4. As a member of hospital accreditation teams, contribute critical IRB procedures to ensure maintenance of AAHRPP accreditation. Assure compliance with required accreditation standards. after accreditation is achieved.
5. Function as liaison between IRB chairs and committee members, government and institutional officials, hospital legal counsel, ORCRA, investigators, the CCHMC research community and research subjects.
6. Serve as the primary topic specific expert to the CCHMC research community for issues related to IRB review of research involving human subjects.
7. Responsible for identification of revised and new government regulations regarding conduct of human subject research and for promulgating this information to the IRB Office, IRBs, investigators, the CCHMC research community and other officials.
8. Responsible for proper identification of risk and potential areas of non-compliance.
9. Supervise, develop and counsel support staff. Prepare and present annual performance evaluations. Evaluate training needs and develop training strategies. Clarify reporting lines and develop written policies and procedures for human subjects protection and all core administrative processes, including training.
10. Improve organizational performance through establishing new procedures and improved activities.
11. Assure that policies and procedures governing the handling of confidential information as defined by Cincinnati Children's Mission and applicable laws and regulations are followed. Review timeliness, accuracy, availability and security of information.
13. Responsible for directing the following activities:
a. Direct all IRB support functions, operations, and document flow.
b. Direct work of vendors and related activity.
c. Report changes in IRB membership to the Office for Human Research Protection (OHRP).
d. Maintain a computerized data base with capability of producing productivity and performance metrics.
14. Recommend approaches for improvement activities, recommend and perform new processes, collect and measure data, develop processes based on performance and communicate results.
15. Maintain currency in field through continuing education, literature and seminars. Implement this knowledge into the ORCRA function.
16. Perform other duties as assigned.
REQUIRED SKILLS: Excellent verbal, written and interpersonal communication skills. Capable of relating to diverse age and demographic backgrounds at various organizational levels. Ability to make decisions and manage the work of others. Demonstrated ability to lead and manage staff. Self motivated with ability to work independently without assistance. Demonstrate diplomacy, tact and a professional demeanor. Computer literate with a working knowledge of software applications (word processing, spreadsheet and database).
EDUCATION\WORK EXPERIENCE: Bachelor's Degree or equivalent required. Five years of related experience with three years of related supervisory experience. Certification as an IRB (CIP) Professional required.
To apply, please visit our website http://www.cincinnatichildrens.org/careers/ and apply for "Manager-IRB".
For questions regarding the position please contact Jeremy Corsmo and jeremy.corsmo@cchmc.org.
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Author |
Date |
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Manager - IRB -- Cincinnati, OH new |
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Jeremy Corsmo |
04-10-08 12:12 |
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