Regulatory Specialist II jobs in United States
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University of Pittsburgh · 1 month ago

Regulatory Specialist II

The University of Pittsburgh is a world-renowned center for excellence in transplantation research and clinical care. The Regulatory Specialist II will work with the clinical research team to ensure compliance with federal regulations, provide training, and manage regulatory documents for clinical trials.

Higher Education
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Responsibilities

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

Qualification

Federal regulations complianceRegulatory protocol trainingProtocol review submissionsDocument verificationComplex issue handlingTeam collaboration

Required

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
Bachelor's Degree
2 years of experience
Combination of education and relevant experience will be considered in lieu of education and/or experience requirement

Preferred

Cover Letter

Company

University of Pittsburgh

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The University of Pittsburgh is a top-ranked, public institution in Pennsylvania and a member of the Association of American Universities of leading research universities.

Funding

Current Stage
Late Stage

Leadership Team

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Alexandra Costlow
Communications Specialist for the CFO / SVC Office
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Narahari Sastry
Senior Vice Chancellor & CFO
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