Clinical Research Regulatory 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

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.