Research Compliance Specialist II

University of Pittsburgh; Pittsburgh (Allegheny County); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory compliance

IRB submissions

Coordination

Grant review support

Ausbildung

Bachelor's Degree in a related field

Jobbeschreibung

Job Description - Research Compliance Specialist II (26006565)

Research Compliance Specialist II

Med-Neurological Surgery - Pennsylvania-Pittsburgh - ( 26006565 )

Job Summary

Serves as regulatory liaison for all clinical sites, coordinating centers, and data management centers and performs grant approval reviews and assists with regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and develops 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 II.

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. IND preparation and 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. Serves as regulatory liaison for multiple clinical sites, coordinating centers, and data management centers for several research studies. Coordinates remote investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations. The University reserves the right to assign other duties to employees that are not listed in this job description.

Minimum education to be considered for this position is a bachelor’s degree in a related field.

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 II

Job Family Compliance & Audit

Job Sub-Family Research Compliance

Campus Pittsburgh

Minimum Education Level Required Bachelor's Degree

Minimum Years of Experience Required 2

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, Evenings and Weekends as needed

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

Hiring Range TBD Based Upon 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.