Clinical Trials Navigator: Streamline Study Startups

The Pennsylvania State University; Hershey (PA); Hybrid; USD 66.000 - 95.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Clinical research experience

IRB/regulatory knowledge

Cross-functional collaboration

Problem-solving

Communication skills

Ausbildung

Master's degree

Tools

Clinical trial management systems

Jobbeschreibung

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.