Description
Regulatory Specialist II
Med-Surgery - Pennsylvania-Pittsburgh - (25006724)
The Thomas E. Starzl Transplantation Institute at the University of Pittsburgh School of Medicine is a world-renowned center for excellence in transplantation research and clinical care.
We are seeking a Regulatory Specialist II to work with our clinical research team in all regulatory issues with clinical trials.
The applicant should be a highly motivated, highly organized person who can work both independently and as part of a team.
Job Summary
Ensures that all federal regulations are adhered to and maintains up-to-date information regarding federal regulations and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents for research communities. Submits protocol reviews, verifies required documents, and handles complex issues.
Essential Functions
• Ensures that all federal regulations are adhered to and followed; maintains up-to-date information regarding federal regulations and ethical considerations.
• Provides training and guidance on regulations protocol review policies and procedures.
• Composes, edits, and distributes information to committee members and research communities.
• Prepares and submits initial, annual, and final protocol reviews to federal, state, and local agencies.
• Identifies, secures, and verifies required documents.
• Provides periodic reports.
• Responds to non-standard inquiries and handles complex issues.
Physical Effort
Little physical effort required. Duties are primarily sedentary. May be required to move objects up to 25 pounds occasionally.
Assignment Category: Full-time regular
Job Classification: Staff.Regulatory 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: Monday - Friday, 8:30am - 5pm
Work Arrangement: Hybrid: Combination of On-Campus and Remote work as determined by the department.
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
Required Documents: Resume
Optional Documents: Cover Letter
PI280501862