Job Overview:
Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
Summary of Responsibilities:
Lead site start-up and activation activities, ensuring compliance with ICH-GCP, local regulations, and study requirements.
Support EC/IRB submissions, regulatory documentation, and site activation deliverables.
Manage essential documents, TMF maintenance, and ongoing site compliance activities.
Conduct feasibility assessments, remote site interactions, and selected IHCRA activities.
Serve as the primary point of contact for investigative sites and collaborate closely with CRAs, Regulatory Leads, and project teams
Qualifications & Experience (Minimum Required):
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
2+ years of experience in clinical research, preferably within Site Start-Up, Regulatory, IHCRA, or CRA functions.
Experience with EC/IRB submissions, regulatory documentation, TMF management, contract and budget negotiations, and site activation activities.
Understanding of ICH-GCP, local regulations, and clinical trial processes.
Fluent English communication skills, both written and verbal.
Previous CRA or IHCRA experience is highly preferred
What We're Looking For:
A scientific degree and/ or clinical expertise is optimal for this role.
Strong attention to detail and ability to follow SOPs and study procedures.
Ability to manage multiple priorities in a fast-paced environment.
Collaborative mindset aligned with Fortrea FOUR culture and values.
Willingness to perform both Site Start-Up and IHCRA responsibilities, including feasibility and remote site activities.
Learn more about our EEO & Accommodations request here.
Skills Required
- University/College degree in life science or related field
- 2-3 years' work experience in clinical research
- Fluent in local official language and in English
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
