Full-time 40 hours/week

Monday-Friday 8am-4:30pm

Hybrid remote (requires 6-12 days/onsite per month in Akron- prefer candidates that reside in NE Ohio)

Summary:

The IRB Specialist provides administrative and operational support to the Institutional Review Board (IRB) and Office of Research Integrity. This role assists with submission intake, document management, research credentialing and training, investigator and study team communications, and IRB system administration.

Responsibilities:

1. Review IRB submissions to verify that all materials provided to the IRB are in compliance with policies, procedures and applicable regulations; Communicate administrative deficiencies identified and assist investigators with submission requirements, routing, and system navigation.

2. Facilitate convened meetings of the IRB, including developing agendas, recording minutes and documenting review activities as assigned.

3. Provide administrative support and advice regarding human subjects research applications submitted to the IRB.

4. Manage routine requests made to the IRB via email or telephone or escalate request to appropriate individual or institutional office.

5. Assist in the preparation of reports and correspondence related to IRB activities,

6. Maintain user accounts in the electronic IRB submission system, including troubleshooting access issues, creating accounts for non-Akron Children's research staff, and supporting routine system updates as needed.

7. Assists with maintaining and distributing IRB policies, standard operating procedures, forms, templates, educational materials, and website content as needed.

8. Process administrative and regulatory review of designated human subjects research application submissions as determined to be appropriate for this role.

9. Other duties as required.

Other information:

Technical Expertise

1. Knowledge and/or experience with clinical trials and/or social and behavioral research, IRB operations, regulations and policies governing research involving human subjects is preferred

2. Strong organizational skills and attention to detail with the ability to manage multiple priorities, maintain accurate records, and meet established deadlines in a regulatory environment.

3.Strong interpersonal skills with the ability to interact professionally with a variety of internal and external collaborators (investigators, research staff and administrators, students, external parties, and IRB members).

4. Good written and oral communication skills

5. Proficiency in Microsoft Office applications, including Outlook, Excel, Word, and other software is required.

6. Experience in human subject research compliance and/or research administration experience is preferred.

Education and Experience

1. Education: Bachelor's degree is required. Equivalent combination of education and direct experience in research-related fields may be considered (High school diploma and a minimum of four (4) years related experience OR Associates Degree and minimum two (2) years related experience)

2. Licensure: NA

3. Certification: None required. Research-related certification (e.g., SOCRA, ACRP, CIP) preferred.

4. Years of relevant experience:Minimum one (1) year of related experience in healthcare, research, or administration is required.

5. Years of supervisory experience: None required.

Full Time

FTE: 1.000000

Status: Fixed Hybrid