Clinical Trials Navigator - Clinical and Translational Science Institute
The Pennsylvania State University
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Job summary
The Penn State Clinical and Translational Science Institute at Penn State College of Medicine is hiring a Clinical Trials Navigator to provide expert guidance and navigation across the clinical research landscape. This role serves investigators and teams, helping move studies from concept to implementation.
Collaborating with CTSI, CTO, and regulatory offices, the Navigator coordinates start-up activities, budgets, and regulatory requirements, ensuring timely support and issue resolution.
Qualifications
- 5-7+ years of progressively responsible clinical research experience in academic medical centers or hospitals.
- Professional certification through a recognized clinical research organization (ACRP/SOCRA/IACRN).
- Demonstrated knowledge of clinical research processes, study start-up activities, and regulatory environment.
- Ability to work collaboratively across units and communicate with colleagues at all levels.
- Strong organizational and problem-solving skills to assess complex situations.
Responsibilities
- Conduct consultations to understand investigator needs and determine next steps.
- Guide investigators to appropriate institutional offices, programs and services.
- Advise on study feasibility, initiation pathways and IND/IDE requirements.
- Assist with budgets, trial management systems, and EMR tools.
- Identify requirements for study initiation and activation.
- Evaluate feasibility including resources, requirements, and barriers to study implementation.
- Navigate IRB, regulatory, contracting, budgeting, pharmacy, labs, imaging, operations, and data processes.
- Coordinate referrals to offices and service providers for timely support.
Skills
Education
Tools
Job description
Approval of remote and hybrid work is not guaranteed regardless of work location.For additional information on remote work at Penn State, seeNotice 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 training need areas 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
- 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 organisational and problem-solving skills, including the ability to independently assess complex situations, identify appropriate resources, and recommend solutions.
- Master's degree
- Experience with investigator-initiated clinical trials
- Experience with IND/IDE processes
- Experience with research billing, study budgets or clinical research agreements
Master's Degree1+ years of relevant experience; or an equivalent combination of education and experience accepted
Required Certifications:None
Employment with the University will require successful completion of background check(s) in accordance with University policies. Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S.
The salary range for this position, including all possible grades, is $65,508.00 - $94,980.00.
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 our Benefits Page.
Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here.
Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473.
Penn State is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university's teaching, research, and service mission.
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