IRB Specialist I - RI Scientific Brackeen

The Regulatory Specialist works with the AWRI (Abigail Wexner Research Institute) Institutional Review Board (IRB) to develop and implement policies and procedures to support the regulatory functions of this committee. This position implements regulatory committee decisions and maintains accurate and detailed records of the committee's actions to ensure that AWRI promotes the ethical conduct of research and complies with federal regulatory requirements.

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* Provides administrative support for all aspects of the Institutional Review Board

* Serves as super-user for AWRI's web-based IRB systems and assists in the design and implementation of process improvements and business flow changes. Works with programmers to develop and maintain systems.

* Serves as the primary resource for investigators regarding the organizational review requirements for research protocols.

* Conducts preliminary administrative review of complex research protocols that propose the use of human subjects in research at AWRI.

* Maintains communication with investigators regarding approaching expirations of study approvals, delinquent responses, incomplete submissions, and other concerns.

* Provides training to investigators and study staff regarding the submission of new protocols or amendments to existing protocols using the system.

* Responds to technical questions concerning federal regulations, policies, and procedures related to human research subjects use at AWRI.

* Tracks pending applications and advises investigators on the status of their submission.

* Supports post approval monitoring program.

* Coordinates filing of AWRI's institutional accreditation applications.

* Maintains records for federal inspections and retains confidential research records and implements distribution schedule in accordance with Federal, State, Professional, and AWRI record-keeping requirements.

* Attends regulatory professional meetings and surveys published literature for new or modified regulations that impact research on human subjects.

Knowledge, Skills & Abilities: Education:

Bachelor's degree or an equivalent combination of education or experience.

Skills:

* Demonstrates ability to analyze and apply Federal, industry regulatory agencies and AWRI's policies.

* Demonstrates written and oral communications skills.

* Demonstrates working knowledge of research terminology.

* Demonstrates ability to work both independently and in a team-oriented environment, to follow through on assignments with minimal directions, and to independently prioritize work.

* Proficient in Microsoft Office Suite software. Experience: Three year's relevant research experience required.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision. EOE M/F/Disability/Vet