University of Pittsburgh · 2 months ago
Program Manager, Hillman Cancer Center
Pittsburgh, PA
Full-time
Onsite
Entry, Mid Level
2+ years expThe University of Pittsburgh is seeking a Program Manager for the Hillman Cancer Center's monitoring and compliance support team. This role involves overseeing compliance activities for clinical research protocols, coordinating regulatory reviews, and ensuring adherence to institutional regulations and policies.
Higher Education
No H1B
Responsibilities
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
Qualification
Required
Bachelor's Degree
2 years of experience
Combination of education and relevant experience will be considered in lieu of education and/or experience requirement
Must be able to lift 10 pounds and travel to various locations on the Oakland and Shadyside campuses
Resume, Cover Letter
Preferred
RN; CCRC Certification through the Association of Clinical Research Professionals and/or CCRP certification through SOCRA are desirable
Company
University of Pittsburgh
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.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Alexandra Costlow
Communications Specialist for the CFO / SVC Office
Narahari Sastry
Senior Vice Chancellor & CFO
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