This may be time for you to join our innovative FSP team as a Clinical Research Associate (CRA) in Romania and be at the forefront of groundbreaking medical advancements in a variety of indications (Oncology, Neurology, Gene Therapy...).
Key Responsibilities:
- Monitor Clinical Trials - conduct site visits to ensure compliance with protocols, regulatory requirements and Good Clinical Practice (GCP)
- Site Management - Serve as the primary point of contact for investigational sites, ensuring smooth study operations.
- Source Document Verification (SDV)- Review and verify accuracy of clinical data collected from study sites.
- Investigator Training and Support - Provide ongoing training to site staff on study protocols and regulatory requirements
- Reporting and Documentation -Prepare monitoring reports, maintain study records, and contribute to overall trial documentation.
Qualifications:
- Life Sciences University degree or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). (Fortrea may consider relevant and equivalent experience in lieu of educational requirements)
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process.
- Fluency in Romanian and in English, both written and verbal.
What We Offer:
- Flexible work arrangements (hybrid /remote options)
- Career growth environment in a supportive environment
- Dedicated Line Manager
- Works directly with a leading sponsor on innovative studies
- Attractive salary and Fortrea benefits
If you are passionate about clinical research, thrive in a collaborative environment, and seek exciting career growth, we want to hear from you!
#LI-Remote #LI-Hybrid
Learn more about our EEO & Accommodations request here.
Skills Required
- Life Sciences University degree or certification in a related allied health profession
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Knowledge of monitoring procedures and understanding of the clinical trial process
- Fluency in Romanian and in English, both written and verbal
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.
