The Education and Compliance Support for Human Subject Research (ECS-HSR) Coordinator will be responsible for monitoring clinical research protocols associated with faculty held investigational drugs and devices, conducting Quality Assurance Reviews, Research Investigator Start-up Education and performing audits as requested. All compliance activities must be summarized in a written report, provided to the applicable Principal Investigator and presented as applicable to the Compliance Activity Review Subcommittee. The ECS-HSR Coordinator will also be responsible for providing education to the research community. Involvement in educational events ranges from one-on-one trainings provided during compliance reviews to presentations at seminars involving faculty, staff and students.
Serves as regulatory liaison for all clinical sites, coordinating centers, and data management centers and performs grant approval reviews and assists with regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.
- Monitor clinical trials conducted under inversigator-sponsored IND or IDE applications.
- Perform quality improvement initiatives/compliance reviews of IRB approved protocols throughout the University.
- Review and analyze research records and medical records for protocol adherence, adverse events and unanticipated problems involving risks to human sujects or others.
- Review IRB correspondence for complex clinical trials.
- Communicate with all levels of faculty and research staff.
- Attend monthly meetings of the Compliance Activity Review Subcommittee.
- Attend IRB Executive Committees as necessary.
- Participate in ECS-HSR educational programs for the research community.
- Maintain up-to-date information regarding federal regulations and ehtical considerations, and IRB policies related to the use of human subjects in research.
- Perform audits as requested by the IRB Executive Committee and Office of Research Protection (ORP) leadership.
- Assist with other ORP activities as needed.
- Computer skills, and excellent verbal and wrtiten communication skills.
Must be able to lift 10 pounds and travel to various locations on the Oakland and Shadyside campuses.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
Job Details
- Assignment Category: Full-time regular
- Job Classification: Staff.Research Compliance 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
- Substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.
- Additional details about Required Licensure/Certification: BSN or MSN with prior human subject biomedical research experience or BS with applicable experience in clinical trials. CCRC Certification through the Association of Clinical Research Professionals and/or CCRP certification through SOCRA and/or CIP certification though PRIM&R are desirable. Prior clinical research experience is preferred. RN, CCRC, CIP preferred.
- 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: 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, Cover Letter
- Optional Documents: Not Applicable