Description
Program Manager, Hillman Cancer Center
Educational and Compliance Office - Pennsylvania-Pittsburgh - (26000901)
This position serves as the Program Manager for the Hillman Cancer Center (HCC) monitoring and compliance support team, which is part of Education and Compliance Support for Human Subject Research (ECS-HSR). The Program Manager will oversee the duties of ECS-HSR HCC team as well as participate in the monitoring of clinical research protocols associated with faculty held investigational new drugs (IND) and investigational device exemptions (IDE). This individual will review, and grade compliance reports issued by ECS-HSR HCC team and may also be required to assist, as needed, with the review and grading of non-Hillman compliance reports. In addition, this position includes performing compliance reviews at the HCC and departments throughout the University. The position also entails reviewing and summarizing monitoring visit findings and identifying issues of concern for discussion at bi-monthly leadership meetings between the leadership of the HCC Clinical Research Service (CRS) team and of the ECS-HSR and the monthly Compliance Activity Review Subcommittee meetings as applicable.
Job Summary
Oversees regulatory liaison for all clinical sites, coordinating centers, and data management centers and performs grant approval reviews and assists with regulatory reviews. Completes investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.
Essential Functions
Leads ECS-HSR HCC compliance team in performing compliance activity reviews of human subject approved protocols, develops training, maintains up-to date information on regulations, ethics, and human subject research policies.
Physical Effort
Must be able to left 10 pounds and travel to various locations on the Oakland and Shadyside campuses.
Assignment Category: Full-time regular
Job Classification: Staff.Research Compliance Specialist III
Job Family: Compliance & Audit
Job Sub Family: Research Compliance
Campus: Pittsburgh
Minimum Education Level Required: Bachelor's Degree
Minimum Years of Experience Required: 3
Will this position accept 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: RN and experience in monitoring clinical trials and FDA regulated research is required. A BSN or a MSN with prior human subject biomedical research experience or BS with applicable experience in clinical trials can be substituted for the RN. CCRC Certification through the Association of Clinical Research Professionals and/or CCRP certification through SOCRA are desirable. Prior clinical experience with direct patient care is 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
Optional Documents: Not Applicable
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