Research Integration Project Manager

Penn State University • New York, NY

94d • $68,200 - $102,300

About The Position

The Research Integration Project Manager position acts as the Liaison for research activities between Penn State Health (PSH) practice sites (excluding Hershey Medical Center (HMC)) and Penn State University (PSU)/College of Medicine (COM) for the purpose of integrating research into PSU/COM standardized processes and policies. As the research integration liaison, this position works closely with COM research departments including, the COM Clinical Trials Office (CTO), COM Office of Research Affairs (ORA), and many other COM research departments. In addition, works closely with PSH Investigational Drug Services, PSH Heart and Vascular Institute, PSH Cancer Institute, PSH offices of Mission and Ministry, PSH Patient Financial Services, PSH Compliance offices, PSH St. Joseph medical and pharmacy residency programs, and additional Penn State Health offices as clinical enterprise needs dictate. This position also liaises and collaborates directly with various University Park enterprise offices, including the Office of Research Protections (ORP) and the Office of Research Information Systems (ORIS) and others as needed.

Requirements

• Master's Degree.
• 3+ years of relevant experience; or an equivalent combination of education and experience accepted.

Nice To Haves

• Familiarity with clinical trial billing regulations, Good Clinical Practices, (FDA) regulations, Federal Wide Assurance (FWA) and Office of Human Research Protections (OHRP) Policy and Procedure.
• Familiarity with COM systems such as CATS IRB, SIMS, COINS, MyResearch Portal and others is a plus.
• Some knowledge of PSH systems including Cerner suite of products, Epic, Infonet, and others as needed is preferred.

Responsibilities

• Serve as facilitator to resolve issues between clinical research department/practice sites, research staff, hospital departments, legal department, administration and external partners.
• Communicate procedural changes to ensure compliance with COM research requirements and assist clinical and research offices to ensure policies are being followed across the Penn State Health non-Hershey practice sites.
• Act as a resource for Clinical Research inquiries and education for non-Hershey based practice site staff.
• Assist the Research Integration Program manager with all aspects of the Research Integration Program including project and operational work.
• Assist in defining and operationalizing research integration processes and policies.
• Onboard newly integrated practice sites to orient and train non-Hershey based research staff to ensure PSU/COM research policies and procedures replace any local research policies.
• Facilitate transfer of Assignment agreements for site research studies and contracts from the practice site to the COM.
• Facilitate access to PSU/COM research systems.
• Interface with external collaborators to direct and facilitate multi-site and collaborative research as needed.
• Co-manage research integration operations including collaborating with PSH leadership of clinical units, departments, or centers to develop strategic partnerships.
• Facilitate intake of new research projects submitted by non-Hershey practice sites.
• Provide leadership and oversight for operationalizing all clinical trials conducted at Penn State Health non-Hershey based sites.
• Communicate with the offices of Mission and Ministry at all Penn State Health Catholic hospitals.
• Work with clinical PSH clinical service lines and COM central research offices to design and implement research integration work-flow processes.
• Build a sustainable research integration program by strategically building and operationalizing an enterprise-wide Clinical Research Operations Group (CROG).
• Analyze research integration workflow, practices and outcomes to measure alignment with organizational goals and objectives and suggest process changes to improve expected outcomes as needed.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Robust retirement plans.
• Substantial paid time off including holidays, vacation and sick time.
• Generous 75% tuition discount available to employees as well as eligible spouses and children.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree