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.
Interested candidates, please go to Home | Talent Center: Careers at Pitt | University of Pittsburgh and use requisition #26003380 to apply for this position.
The University of Pittsburgh is an Affirmative Action/ Equal Opportunity Employer and 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.
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
Required Documents: Resume
Optional Documents: Not Applicable
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