Works with the Abigail Wexner Research Institute (AWRI) Regulatory Committees (IRB or IACUC) to develop and implement policies and procedures to support the regulatory functions of those committees.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.
Essential Functions:
- Provides administrative support for all aspects of the AWRI Regulatory Committees (IRB or IACUC).
- Serves as super-user for AWRI's web-based 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 or animals 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 or animal research 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 or animal subjects.
Education Requirement:
Bachelor's degree or an equivalent combination of education or experience.
Licensure Requirement:
(not specified)
Certifications:
(not specified)
Skills:
- Ability to analyze and apply Federal, industry regulatory agencies and AWRI's policies.
- Effective verbal and written communication.
- Working knowledge of research terminology.
- Ability to work both independently and in a team-oriented environment, under minimal direction.
- Proficiency with MS Office.
Experience:
Three years of relevant research experience, required.
Physical Requirements:
OCCASIONALLY: Bend/twist, Climb stairs/ladder, Lifting / Carrying: 0-10 lbs, Pushing / Pulling: 0-25 lbs, Reaching above shoulder, Squat/kneel, Standing, Walking FREQUENTLY: (none specified) CONTINUOUSLY: Audible speech, Color vision, Computer skills, Decision Making, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near, Sitting
Additional Physical Requirements performed but not listed above:
Ability to multi-task within a demanding environment "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 individuals 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 their supervision. EOE M/F/Disability/Vet"
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Nationwide Children's Hospital
Jul 07, 2025