What are the responsibilities and job description for the Regulatory Specialist II position at University of Pittsburgh?
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.
Med-Surgery
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.
Essential Functions
Little physical effort required. Duties are primarily sedentary. May be required to move objects up to 25 pounds occasionally.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
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
Med-Surgery
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.
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.
Little physical effort required. Duties are primarily sedentary. May be required to move objects up to 25 pounds occasionally.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
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