IRB Compliance Specialist, Senior
DescriptionUniversity Research Services Administration (URSA), Research Integrity is seeking to hire a IRB Compliance Specialist, Senior. The scope of responsibility will include these essential duties but is not limited to the following,
- Assists in the implementation of mechanisms to ensure the University's policy on human subject research is consistent with federal regulations and accreditation standards. Accreditation includes implementation of quality standards and monitoring system for which this position provides support to include assistance with conducting monitoring and/or auditing of proposals for compliance with the approval granted for the project.
- Assists in the updating of a variety of manuals and forms required by federal agencies and accreditation standards.
- Assists in updating the IRB website on the URSA site.
- Conducts expedited reviews, exempt study review determinations, continuing reviews, status updates and study Closures. Makes determination of non-human subjects research according to regulatory requirements. Processes expedited amendments including studies in data analysis; personnel updates; site modifications; modifications to the number of participants and sponsorship modifications. Serves as a voting member or alternate member of the IRB committee as appointed by the Vice President for Research and Economic Development. This requires reviewing submitted proposals for regulatory compliance.
- Coordinated IRB meeting activities including preparing meeting agendas and minutes according to regulatory and accreditation requirements.
- Creates and maintains office files and documents according to regulatory requirements and accreditation requirements.
- Maintains daily administrative operations for the efficient and timely processing of all human subject research protocols. Composes correspondence to investigators that requires a comprehensive level of expertise and knowledge of regulations, accreditation standards and university policies to ensure all concerns and technical questions are timely, concisely and intelligibly communicated to investigators. Provides timely follow up with investigators. Serves as a liaison between IRB, investigators and research administrators. Provides training to investigators and IRB members. Actively communicates daily with investigators answering questions and providing appropriate documentation.
- Maintains the human subject's database and assists with the electronic protocol management system operation including work flows, branching logic, forms preparation and training of users
- Develops and conducts training on IRB processes.
- Provides specific training to investigators on IAA/Reliance Agreements and use of software processes and interface for SMART IRB and Commercial IRBs.
- Serves as Administrative backup for all IRB meetings (e.g. coordinates IRB meeting activities including preparing meeting agendas and minutes according to regulatory and accreditation standards.
QualificationsBachelor's degree and three years of experience in a human subject protection program; or a combination of education and related experience. Collaborative Institutional Training Initiative (CITI) Training preferred. Experience working in an academic setting preferred. Certification as IRB Manager or IRB Professional preferred.
College/Business Unit04/15/19, 10:59:00 PM
College/Business Unit: Research & Sponsored Programs
Location: Atlanta Campus
Job Posting: 05/01/19, 6:22:52 AM