Program Manager, Hillman Cancer Center
Educational and Compliance Office - Pennsylvania-Pittsburgh - (25006504)

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 and supervise the 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 duties include but are not limited to:

• Overseeing the HCC ECS-HSR team. This includes making monitoring assignments, reviewing, and grading HCC ECS-HSR compliance reports, orienting new team members and conducting annual performance reviews
• Overseeing and participating in the monitoring of clinical research protocols associated with faculty held investigational new drugs (IND) and investigational device exemptions (IDE)
• Reviewing IRB correspondence for complex clinical trials
• Communicating with all levels of faculty and research staff
• Reviewing and analyzing research records and medical records for protocol adherence, adverse events, and unanticipated problems involving risks to human subjects or others
• Working with the Sponsor-Investigator and ECS-HSR Director to develop a monitoring plan for clinical trials conducted under investigator-sponsored IND or IDE applications
• Working with the Director of HCC Clinical Research Services (CRS) to ensure compliance with implementation of corrective actions to address compliance activity findings
• Performing compliance reviews at the HCC and throughout the University
• Reviewing and grading of all ECS-HSR Hillman team reports to include monitoring visit reports, Research Investigator Start-up Education (RISE) Interviews, Quality Assurance Reviews (QARs), and audit reports. This function also includes providing a summary of the primary issues identified in the report in the ECS database so that succinct information is available for the monthly Compliance Activity Review (CAR's) agenda
• Serving as a resource for the ECS-HSR Hillman team in interpreting adherence to the outlined study intervention; assessing toxicity grades; and evaluating the research team's assessment, reporting, documentation of adverse events and the REDCap data verification process
• Identifying trends or issues of concern for discussion at bi-monthly ECS-HSR / CRS leadership meetings
• Attending CRS-Biostats Biweekly IIT Meetings to ensure data cleaning prior to data analysis
• Attending IRB Executive Committee Meetings and presenting compliance visit findings as applicable
• Assisting with the preparation of FDA inspections at the HCC
• Assisting with for cause audits, as needed

• Participating in ECS-HSR educational programs for the research community

• Orienting new members of the ECS-HSR Hillman team
• Maintaining up-to-date information regarding federal regulations and ethical considerations, and IRB policies related to the use of human subjects in research. This responsibility includes notifying investigators and/or research coordinators about changes in federal regulations and ethical considerations that affect research involving human subjects

Additional Education/Experience:

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. Experience in monitoring clinical trials and FDA regulated research is preferred. Prior clinical experience with direct patient care is preferred.

Job Summary

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.

Essential Functions

Leads HCC ECS 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 lift 10 pounds and travel to various locations on the Oakland and Shadyside campuses.

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
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; CCRC Certification through the Association of Clinical Research Professionals and/or CCRP certification through SOCRA are 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: 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

Equal employment opportunity, including veterans and individuals with disabilities.

PI280053136