Director, Education and Compliance Support for Human Subject Research jobs in United States
cer-icon
Apply on Employer Site
company-logo

University of Pittsburgh · 5 hours ago

Director, Education and Compliance Support for Human Subject Research

The University of Pittsburgh is seeking a Director for Education and Compliance Support for Human Subject Research. This role involves leading a team to oversee all operational aspects of the research program, ensuring compliance with regulations, and developing training programs for faculty engaged in human subject research.

Higher Education
badNo H1Bnote

Responsibilities

Oversees all ECO‑HSR operations within the Office of Research Protections
Develops University‑wide compliance monitoring strategies for human subject research
Designs and delivers regulatory training and education programs
Maintains up‑to‑date knowledge of regulatory changes to guide training needs
Reviews investigator‑sponsor requests for multicenter trials under Pitt‑held INDs/IDEs
Serves as liaison to OHRP, FDA, NIH, and other agencies during audits and inspections
Collaborates with Hillman Cancer Center Clinical Research Services on monitoring of clinical protocols for faculty‑held IND/IDE
Works with Health Sciences IT on clinical research–supporting technology initiatives
Partners with the Human Research Protection Division on policies, guidance, and Association for Accreditation of Human Research Protection Program application
Serves on the IRB Executive Committee, Conflict of Interest Committee, and Institutional Conflict of Interest Committee
Participates in ORP Leadership, and other University clinical trial group initiatives
Reviews ECS‑HSR compliance reports, ensuring regulatory adherence and corrective actions
Oversees the Compliance Activity Review Subcommittee (CARS)
Conducts for‑cause audits at the request of IRB, ORP, or Pitt Research leadership
Attends IRB Executive Committee meetings and provides requested compliance feedback
Works with Sponsor‑Investigators and research teams to develop monitoring plans for investigator‑sponsored IND/IDE studies

Qualification

Human Subject ResearchRegulatory ComplianceClinical Trials ManagementClinical Practices (GCP)FDA Regulatory AssistanceTraining DevelopmentFinancial ManagementMonitoring StrategiesLeadershipCollaboration

Required

Bachelor's Degree
7 years of experience
Successful completion of a background check for position finalists
Resume
Cover Letter

Preferred

Certification as an IRB or Research professional is desirable

Company

University of Pittsburgh

company-logo
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

leader-logo
Alexandra Costlow
Communications Specialist for the CFO / SVC Office
linkedin
leader-logo
Narahari Sastry
Senior Vice Chancellor & CFO
linkedin
Company data provided by crunchbase