Clinical Trials Navigator - Clinical and Translational Science Institute

Penn State University • Tallahassee, FL

13d • $65,508 - $94,980 • Onsite

About The Position

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.

Requirements

• 5 – 7+ years of progressively responsible clinical research experience, including experience with interventional clinical trials and industry-sponsored research, preferably in an academic medical center or hospital
• Professional certification through a recognized clinical research organization, such as ACRP, SOCRA, or IACRN
• Demonstrated knowledge of clinical research processes, study start-up activities, and the research regulatory environment
• Demonstrated ability to work collaboratively across organizational units, communicate effectively with colleagues at all levels, and build productive relationships
• Strong organizational and problem-solving skills, including the ability to independently assess complex situations, identify appropriate resources, and recommend solutions.
• Master's Degree 1+ years of relevant experience; or an equivalent combination of education and experience accepted
• Applicants must be authorized to work in the U.S.

Nice To Haves

• Master’s degree
• Experience with investigator-initiated clinical trials
• Experience with IND/IDE processes
• Experience with research billing, study budgets or clinical research agreements

Responsibilities

• 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

Benefits

• comprehensive medical, dental, and vision coverage
• robust retirement plans
• substantial paid time off which includes holidays, vacation and sick time
• 75% tuition discount, available to employees as well as eligible spouses and children

What This Job Offers

• Job Type: Full-time
• Career Level: Senior