Regulatory Specialist

Experience conducting regulatory activities for Coordinating Center trials preferred.

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.

-Prepares and maintains regulatory documents and Institutional Review Board (IRB) submissions

-Monitors, tracks and reports all Serious Adverse Events to IRB and Sponsor

-Ensures safety letters (i.e. MedWatch reports) are reviewed by the Principal Investigator and submitted to the IRB and external sites

-Oversees preparation of all closed study files for archiving in long term storage

-Serves as contact for research projects and maintains records and corresponds with all parties involved

-Develops and continuously monitors status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatory compliance for external sites

Must be able to sit or stand for prolonged period of time.

The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.

The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.