Clinical Trials Navigator - Clinical and Translational Science Institute

Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants.

This position is funded for 12 months; continuation past 12 months will be based on university need, performance, and/or availability of funding.

The Penn State Clinical and Translational Science Institute (CTSI) at Penn State College of Medicine is hiring a Clinical Trials Navigator.

The Clinical Trials Navigator serves as a centralized resource for faculty investigators and clinical research teams, providing expert guidance, consultation and navigation across the clinical research landscape. The Navigator helps investigators and research teams identify and access appropriate institutional resources, understand clinical research processes and requirements, and efficiently move studies from concept to implementation.

Working collaboratively with the CTSI, Clinical Trials Office (CTO), and regulatory and compliance offices, the Clinical Trials Navigator serves as a trusted point of contact and connector for investigators navigating complex clinical research processes.

• Conduct consultations to understand investigator needs, identify barriers and determine appropriate next steps
• Guide investigators to the appropriate institutional offices, programs and services
• Advise on study feasibility, study initiation pathways and IND/IDE requirements
• Serve as a resource on clinical research budgets, costs, clinical trial management systems and electronic medical record tools

• Assist investigators and research teams in identifying requirements for study initiation and activation
• Support research teams in feasibility assessment of sponsored clinical trials, including evaluation of institutional capabilities, operational requirements, resource needs, and potential barriers to study implementation
• Support navigation of IRB, regulatory, contracting, budgeting, pharmacy, laboratory, imaging, clinical operations, data and other ancillary requirements
• Coordinate and monitor referrals to institutional offices and service providers to ensure timely support and issue resolution

• Develop standardized navigation tools, workflows, FAQs and other resources for investigators and research staff
• Identify areas of training need and programs to connect research teams with appropriate educational resources and develop solutions and training materials – in collaboration with iSMART program - to address unmet needs.

• Develop and maintain knowledge of institutional clinical research resources, policies, processes and points of contact
• Build relationships across clinical, research and administrative units to facilitate collaboration
• Serve as the CTSI’s point of contact for the NIH/National Center for Advancing Translational Sciences (NCATS) Trial Innovation Network
• Assist with the coordination and management of Site-Sponsor/CRO relationships, including facilitating communication, addressing issues, and connecting sponsors and CROs with appropriate institutional resources and contacts
• Identify, triage, and direct sponsored research opportunities to appropriate faculty investigators and research teams based on study requirements, investigator expertise, and institutional capabilities

• Track Navigator consultations, referrals, services and outcomes
• Analyze recurring investigator questions and barriers to identify system-level improvement opportunities
• Prepare reports summarizing Navigator activities, trends, barriers and opportunities