| IRB Manager -- Research Triangle Park, NC |
Author: Jon Merz
Date: 07-01-09 18:30
IRB Manager - RTI International
About RTI
RTI is an independent organization dedicated to conducting innovative, multidisciplinary research that improves the human condition. With a worldwide staff of more than 4,000 people, RTI offers innovative research and development and a full spectrum of multidisciplinary services. Universities in North Carolina founded RTI in 1958 as the first scientific organization in and centerpiece of the Research Triangle Park.
Job Description:
RTI International seeks an IRB Manager to join the Office of Research Protection. The Office of Research Protection is responsible for ensuring compliance with all regulations related to the protection of human research subjects. This includes maintaining RTI's Federalwide Assurance (FWA) with OHRP, operating three IRB committees, conducting exemption determinations and expedited reviews, assisting RTI researchers in developing appropriate procedures for their studies, and providing training to IRB members and researchers in human subjects protections. The Office strives to maintain a collaborative relationship with researchers with the shared goal of conducting ethical human research at RTI.
Reporting to the Director of the Office of Research Protection, the IRB Manager will be responsible for managing the day to day operations of the Office, and for improving IRB practices, compliance, and operational efficiencies for the review of over 900 active human research projects.
Responsibilities:
The IRB Manager would be responsible for:
* Leading efforts to improve compliance with human subjects protection policies and procedures, with a focus on continuous improvement;
* Updating and maintaining the IRB SOPs to ensure accurate information and compliance with applicable regulations and guidance, and suggesting changes to the IRB Director;
* Assisting the Director with the implementation and administration of a new electronic submission system designed to improve operational efficiencies in IRB reviews;
* Applying DHHS and FDA federal regulations for the protection of human subjects to specific research situations;
* Serving as an ex officio IRB member;
* Conducting exempt determinations and expedited protocol reviews;
* Acting as back-up for the IRB Administrators;
* Consulting with researchers as needed on IRB requirements or human subjects protection issues;
* Designing and planning special projects designed to enhance office procedures, IRB performance, or overall human subjects protections;
* Initiating the AAHRPP accreditation process and preparing related documents;
* Participates in development and delivery of human subjects outreach and training programs;
* Providing support to the Director in other regulatory and
administrative tasks.
Qualifications:
* BA/BS degree, preferably in a research, scientific or related
technical field;
* MBA/MA/MS degree would be a plus;
* Certified IRB Professional (CIP) or Certified IRB Manager (CIM);
* At least 7 years of experience in IRB administration is required. Prior experience as an IRB manager or IRB coordinator for an academic, government, or commercial organization is preferred;
* Experience conducting exempt determinations and/or expedited reviews;
* Experience as an IRB member would be a plus;
* Extensive knowledge of both DHHS (45 CFR 46) and FDA (21 CFR 50 and 56) human subjects regulations and appreciation of related regulatory, ethical and compliance principles;
* Familiarity with other regulations and guidance (e.g., HIPAA) that may be applicable in some human subjects studies conducted by RTI researchers;
* Knowledge or experience with IRB accreditation standards and
processes;
* Membership in national or regional human subjects organization is preferred;
* This position requires excellent organizational skills and strict attention to detail. The candidate must be fluid in "multi-tasking" and have demonstrated independent analytical and problem solving abilities;
* This position requires strong oral and written communication and interpersonal skills that will be necessary to interact with multiple individuals and entities across a large organization.
Equal Employment Opportunity. We are proud to be an EEO/AA employer M/F/D/V.
Visit http://www.rti.org under Careers for information about how to apply. Refer to Job ID 12059.
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Author |
Date |
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IRB Manager -- Research Triangle Park, NC new |
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Jon Merz |
07-01-09 18:30 |
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