About the Role
This unique hybrid role blends the responsibilities of site start‑up, site navigation, and clinical monitoring. As a SCRA / Site Navigator II, you will serve as a trusted partner to investigative sites across the full study lifecycle—from feasibility and activation through monitoring and close‑out. You will play a critical role in ensuring regulatory compliance, patient safety, data integrity, and high‑quality delivery across clinical trials.
Key Responsibilities
Act as the primary point of contact for investigative sites across start‑up, activation, and monitoring phases
Coordinate site‑level activities from feasibility and outreach through site activation and ongoing maintenance
Conduct remote and on‑site monitoring visits, including routine, initiation, and close‑out visits
Ensure compliance with ICH/GCP, local regulations, SOPs, and protocol requirements
Manage regulatory submissions, IRB/IEC interactions, essential documents, and TMF quality
Verify informed consent processes and ensure patient rights, safety, and wellbeing are protected
Perform source data review, CRF review, query resolution, and data validation
Track site performance, risks, and timelines, escalating issues proactively
Support contract and budget negotiations with investigative sites
Collaborate closely with CRAs, project managers, sponsors, vendors, and internal stakeholders
Maintain audit‑ready sites and documentation at all times
Experience & Qualifications
Degree in life sciences or a related field, or equivalent clinical research experience
5+ years of experience across clinical research start‑up, site management, and/or clinical monitoring
Strong working knowledge of ICH/GCP, regulatory requirements, and clinical trial processes
Experience working directly with investigative sites and cross‑functional project teams
Excellent organizational, communication, and stakeholder management skills
Confidence managing multiple priorities in a fast‑paced, matrixed environment
Willingness to travel as required for monitoring and training activities
Learn more about our EEO & Accommodations request here.
Skills Required
- University/College degree or certification in a related allied health profession
- 3+ years' work experience in clinical research or relevant experience with high school diploma
- Fluent in local official language and in English
- Minimum of 2+ years of experience in clinical development or start-up/regulatory process
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.
