Research Compliance Specialist I

University of Pittsburgh; Pittsburgh (Allegheny County); On-site; USD 55,000 - 75,000; Full time

Job summary

The University of Pittsburgh is seeking a Research Compliance Specialist I to support regulatory activities for neurological surgery research projects on campus. This role focuses on coordinating with study teams, submitting IRB documentation, and maintaining compliant regulatory files.

FDA reporting experience is preferred but not required; strong organization and attention to detail are essential to ensure adherence to institutional and federal guidelines across research activities.

Qualifications

• Bachelor's degree required or equivalent.
• Minimum 1 year of related experience.
• Substitution in lieu of education/experience may be considered.

Responsibilities

• Serve as regulatory liaison for clinical sites, coordinating centers, and data management centers.
• Prepare and submit IRB applications, amendments, continuing reviews, and reports.
• Maintain organized regulatory files to ensure compliance with institutional and federal guidelines.
• Collaborate on multisite sIRB studies and assist with overall study execution.

Skills

Regulatory compliance

IRB submissions

Study coordination

Regulatory documentation

Education

Bachelor's Degree

Job description

Job Description - Research Compliance Specialist I (26003380)

Research Compliance Specialist I

Med-Neurological Surgery - Pennsylvania-Pittsburgh - (26003380)

Job Summary

Assists to serve as regulatory liaison for all clinical sites, coordinating centers, and data management centers and assists with grant approval reviews and regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and collaboratively assists with developing approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.

Essential Functions

The University of Pittsburgh Department of Neurological Surgery is hiring a Research Compliance Specialist I.

This position will be responsible for Regulatory duties for neurological surgery research studies and assist as needed with study coordination, not as primary coordinator. Manage regulatory responsibilities for research efforts in the Department of Neurosurgery, including coordinating with study team members to prepare and submit IRB applications (study start-up, modifications, continuing reviews, and required reporting). Maintain well-organized regulatory documentation to ensure compliance with institutional and federal guidelines. FDA reporting experience is preferred but not required. Collaborate with external sites to obtain regulatory approvals and support the management of regulatory files for multisite sIRB studies. Assist other study staff with duties related to overall study execution to ensure efficient and compliant project operations. The University reserves the right to assign other duties to employees that are not listed in this job description.

The University of Pittsburgh is an Affiant ... values equality of opportunity, human dignity, and diversity, EOE, including disability/vets.

Physical Effort

Lab - Requires some bending, stooping, and stretching. Walking around laboratory benches and various common laboratory rooms within the Division. The candidate will use stairs often and may have to make multiple trips between common equipment rooms between floors. Requires normal range of hearing and eyesight to record, prepare, and communicate laboratory methods and results. Requires lifting up to 20lbs.

The University of Pittsburgh is an equal opportunity employer / disability / veteran.

Assignment Category Full-time regular

Job Classification Staff.Research Compliance Specialist I

Job Family Compliance & Audit

Job Sub-Family Research Compliance

Campus Pittsburgh

Minimum Education Level Required Bachelor's Degree

Minimum Years of Experience Required 1

Will this position accept substitution in lieu of education or experience? Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Work Schedule M-F 8:30am-5pm Occasional Mornings, Evening and Weekends as needed

Work Arrangement On-Campus: Teams that work on campus, in an office, or in a lab.

Hiring Range To be determined based on qualifications

Relocation Offered No

Visa Sponsorship Provided No

Background Check For position finalists, employment with the University will require successful completion of a background check

Child Protection Clearances Not Applicable

The University of Pittsburgh is an equal opportunity employer / disability / veteran.