Job Overview:
Location: Warsaw (hybrid role)
We are looking for a clinical operations professional to join our team as Site Navigator I, managing clinical trial start‑up activities with additional in‑house CRA responsibilities. This is an excellent, comprehensive role for someone looking to grow their career in clinical research within a global CRO environment.
Summary of Responsibilities:
- Perform site identification, feasibility, and start‑up activities, including site outreach, feasibility questionnaires, and confidentiality agreements
- Coordinate and track essential regulatory documents to ensure timely and compliant site activation
- Act as a primary point of contact for investigative sites during the start‑up and occasionally the maintenance phase
- Perform ethics committee and regulatory authority/EU CTR submissions, renewals, and prepare the relevant regulatory documentation in collaboration with internal teams
- Perform site contracts and budget negotiations under guidance
- Perform remote Pre-Study Visits
- Support Site Initiation Visit (SIV) preparation, including coordination of documents, systems access, and study supplies
- Perform remote/in‑house CRA activities, such as document review, CRF review, data validation, and remote monitoring tasks (after required training)
- Maintain accurate documentation in study systems and ensure the TMF is inspection‑ready
- Collaborate closely with CRAs, project teams, and study stakeholders to support study milestones
Qualifications (Minimum Required):
- University degree (life sciences preferred)
- Minimum 1 year experience in Clinical Operations or Start-Up
- Knowledge of ICH/GCP and clinical trial processes
- Fluent Polish and English (written and spoken)
- Strong organizational skills, attention to detail, effective communication and willingness to learn
- Ability to manage multiple tasks in a structured and proactive way
Learn more about our EEO & Accommodations request here.
Top Skills
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.
