Regulatory Liaison - Neuro Surgery Research

University of Pittsburgh; Pittsburgh (Allegheny County); On-site; USD 70,000 - 90,000; Full time

Job summary

The University of Pittsburgh Department of Neurological Surgery is seeking a Research Compliance Specialist II to serve as regulatory liaison for clinical sites, coordinating centers, and data management centers, and to manage grant reviews and regulatory support for neurosurgery research.

Responsibilities include preparing and submitting IRB applications, maintaining regulatory documentation, assisting with investigations, and collaborating with external sites on multisite sIRB studies.

Qualifications

• Bachelor's degree in a related field required.
• At least 2 years of experience in research compliance.
• IND preparation and FDA reporting experience preferred but not required.

Responsibilities

• Serve as regulatory liaison for clinical sites, coordinating centers and data management centers.
• Coordinate investigator training sessions and assist with compliance investigations.
• Prepare and submit IRB applications (start-up, modifications, continuing reviews, required reporting).
• Maintain organized regulatory documentation to ensure compliance with institutional and federal guidelines.
• Collaborate with external sites to obtain regulatory approvals for multisite sIRB studies and support overall study operations.

Skills

Regulatory compliance

IRB submissions

Coordination

Grant review support

Education

Bachelor's Degree in a related field

Job description

The University of Pittsburgh Department of Neurological Surgery is seeking a Research Compliance Specialist II to serve as regulatory liaison for clinical sites, coordinating centers, and data management centers, and to manage grant reviews and regulatory support for neurosurgery research.

Responsibilities include preparing and submitting IRB applications, maintaining regulatory documentation, assisting with investigations, and collaborating with external sites on multisite sIRB studies.