Clinical Trials Navigator - Clinical and Translational Science Institute

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POSITION SPECIFICS​

• Position Summary 

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

  The ClinicalTrials Navigator serves as a centralized resource for faculty investigators and clinical research teams,providing expert guidance,consultation and navigation across the clinicalresearch landscape.The Navigator helps investigators and research teamsidentify and accessappropriate institutional resources, understand clinical research processes and requirements, and efficiently movestudies from concepttoimplementation. 
   

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

  Essential Functions 

  Clinical Research Consultation and Navigation 

  • Conduct consultations to understand investigator needs,identify barriers and determineappropriate next steps 

  • Guide investigators to theappropriate institutional offices,programs and services 

  • Adviseon study feasibility, study initiationpathways and IND/IDErequirements 

  • Serve as a resource on clinical research budgets, costs, clinical trial managementsystems and electronic medical record tools 
     

  Study Start-Up and Activation Support 

  • Assist investigators and research teams inidentifying requirements for study initiation and activation 

  • Supportresearch teams infeasibility 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 ancillaryrequirements 

  • Coordinate andmonitor referrals to institutional offices and service providers to ensuretimely support and issue resolution 

  Education and Training 

  • Develop standardized navigation tools, workflows, FAQs and other resources for investigators and research staff 

  • Identifyareas of training need and programs to connect research teams withappropriate educational resources and develop solutions and training materials – in collaboration withiSMART program - to address unmet needs. 

  ResearchPartnerships & Network Engagement 

  • Develop andmaintain knowledge of institutional clinical research resources, policies,processes and points of contact 

  • Build relationships across clinical, research and administrative units tofacilitate 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 withappropriate institutional resources and contacts  

  • Identify, triage, and direct sponsored research opportunities toappropriate faculty investigators and research teams based on study requirements, investigatorexpertise, and institutional capabilities 

  Program Evaluation and Reporting 

  • Track Navigator consultations, referrals,services and outcomes 

  • Analyze recurring investigator questions and barriers toidentify system-level improvement opportunities 

  • Prepare reports summarizing Navigator activities, trends,barriers and opportunities 
     

  Qualifications 

  • 5 – 7+ years of progressively responsible clinical research experience,including experience with interventional clinical trials and industry-sponsored research,preferably in an academic medicalcenter 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 effectivelywith colleagues at all levels, and build productive relationships 
     

  • Strongorganizational and problem-solving skills, including the ability to independently assess complex situations, identifyappropriate resources, and recommend solutions. 

  Preferred  

  • Master’s degree  

  • Experience with investigator-initiated clinical trials 

  • Experience with IND/IDE processes 

  • Experience with research billing, studybudgets or clinical research agreements 

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

BACKGROUND CHECKS/CLEARANCES

SALARY & BENEFITS

Salary Structure- Information on Penn State's salary structure

Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit ourBenefits Page.

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