IRB Compliance Specialist

IRB Compliance Specialist

University Research Services and Administration

Georgia State University

Regulatory Affairs

The Human Research Protection Program (HRPP) in Regulatory Affairs is a vital part of University Research Services & Administration (URSA), under the Office of the Vice President for Research & Economic Development. As a key component within the HRPP, the Institutional Review Board (IRB) plays a crucial role in safeguarding the rights and welfare of human research participants involved in studies under the auspices of Georgia State University.

In the HRPP, we are a team of motivated individuals, driven by collaboration, innovation, and a shared commitment to excellence. The team is dedicated to supporting human subjects research and ensuring the protection of research participants through efficient and effective processes.

The Department is seeking (1) dedicated and experienced (IRB Compliance Specialist)

WHAT MAKES (School) GREAT PLACE?

* A flexible work environment

* Generous benefits, including health, dental, vision, tuition assistance, retirement, etc.

* A knowledge-sharing organization that works collaboratively with diverse partners.

* Professional development opportunities and mentorship

* A rapidly growing center within an academic setting

HERE IS WHAT YOU WILL DO

• The essential duties and responsibilities of the (IRB Compliance Specialist) are the following:
• Maintains assigned daily administrative operations for the efficient and timely processing of all human subject research protocols.
• Processes IRB submissions as assigned.
• Composes correspondence to investigators that requires developing 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. May assist with training investigators and IRB members as knowledge level increases.
• Actively communicate daily with investigators answering questions and providing appropriate documentation.
• Creates and maintains office files and documents according to regulatory requirements and accreditation standards.
• May aid in the updating of a variety of manuals and forms required by federal agencies and accreditation standards.
• Helps as directed with coordination of IRB meeting activities according to regulatory and accreditation requirements.
• Maintains the human subject's database as assigned and assists with the electronic protocol management system operating including workflows, branching logic, forms preparation and testing, and training of users.
• Assists in updating the IRB website on the URSA site.
• Accreditation standards. Accreditation includes implementation of quality standards and monitoring systems 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.

Minimum Requirements:

• Bachelor's degree and one year of experience in human subject protection; or a combination of education and related experience.

Preferred Hiring Qualifications:

• Collaborative Institutional Training Initiative (CITI) training and Certified IRB Professional (CIP); Certified Senior IRB Specialist, Certified IRB Manager or Certified IRB Professional and experience working in an academic setting.

To be fully considered for this position all candidates must submit the following at the time of submission:

* A complete and accurate GSU application

* Resume

* Cover Letter

* Three professional references

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