Director, Education and Compliance Support for Human Subject Research Educational and Compliance Office - Pennsylvania-Pittsburgh - (26000615)
The Director for Education and Compliance Support for Human Subject Research (ECS-HSR) is responsible for ensuring that University members performing human subject research are cognizant of and compliant with all policies, regulations and Good Clinical Practices (GCP) requirements. The individual has oversight and administrative management of three primary areas with the ECS-HSR Division:
- Monitoring and Compliance Support which provides local monitoring services for human subject research when Pitt faculty are the sponsor of an IND or IDE, as well as education and assistance to other clinical trial researchers.
- Clinical Trial Registration and Transparency Support which provides education and assistance to investigators and study staff with registration and results submission to ClinicalTrials.gov.
- IND and IDE Support (IIS) which provides education and FDA regulatory assistance to faculty who serve as the sponsor of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application.
The Director is responsible for formulating and introducing new policies and guidelines required to maintain compliance with all regulations regarding human subject research. They are also responsible for formulating and monitoring the Division’s annual budget and supervising, evaluating and coaching employees.
Clinical background and experience in the conduct of human subject research and regulatory compliance are required. A Master's in Science or Public Policy with prior human subject research and experience in the biomedical field is preferred. Preference will be given to candidates who have demonstrated strong organizational, writing, communication, and problem-solving skills, and the ability to multi-task.
Job SummaryLeads a team and directs & oversees all operational aspects of the research program. Establishes and drives the vision, policies, fiscal functions, administration, and strategic plan of a research program to support the delivery of high-quality research services and ensure compliance with established professional, regulatory, and organizational standards and requirements. Formulates budgets and performs associated financial duties. Collaborates with and advises internal and external stakeholders and ensures adherence to regulations. Translates strategic plans into research operational plans oversees administrative matters.
Essential Functions
- Oversees all ECOHSR operations within the Office of Research Protections
- Develops Universitywide compliance monitoring strategies for human subject research
- Designs and delivers regulatory training and education programs
- Maintains uptodate knowledge of regulatory changes to guide training needs
- Reviews investigatorsponsor requests for multicenter trials under Pittheld 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 facultyheld 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 ECSHSR compliance reports, ensuring regulatory adherence and corrective actions
- Oversees the Compliance Activity Review Subcommittee (CARS)
- Conducts forcause audits at the request of IRB, ORP, or Pitt Research leadership
- Attends IRB Executive Committee meetings and provides requested compliance feedback
- Works with SponsorInvestigators and research teams to develop monitoring plans for investigatorsponsored IND/IDE studies
Physical Effort
The position is generally sedentary. However, the individual must be able to attend occasional on-site monitoring/audit visits and meetings on campus.
Assignment Category: Full-time regular
Job Classification: Staff.Director - Research Operations
Job Family: Research
Job Sub Family: Research Operations
Campus: Pittsburgh
Minimum Education Level Required: Bachelor's Degree
Minimum Years of Experience Required: 7
Will this position accept substitution in lieu of education or experience: No
Additional details about Required Licensure/Certification: Certification as an IRB or Research professional is desirable.
Work Schedule: Monday-Friday, 8:30 a.m.- 5:00 p.m.
Work Arrangement: Hybrid: Combination of On-Campus and Remote work as determined by the department.
Hiring Range: To be determined based on 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, Cover Letter
Optional Documents: Not Applicable
Equal employment opportunity, including veterans and individuals with disabilities.
PI282003750
