CRA II - FSP, Romania

Work set-up: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 
Romania

Offer summary

Qualifications:

Bachelor's degree in Life Sciences or related health profession., Knowledge of ICH GCP guidelines and local regulations., Fluency in Romanian and English, both written and spoken., Experience in clinical trial monitoring or site management is preferred..

Key responsibilities:

  • Conduct site visits to monitor trial compliance and data accuracy.
  • Serve as the primary contact for investigational sites to ensure smooth operations.
  • Provide training and support to site staff on study protocols and regulations.
  • Prepare reports and maintain documentation related to clinical trials.

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Fortrea XLarge https://fortrea.com/
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Job description

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.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Spoken language(s):
MoldovanEnglish
Check out the description to know which languages are mandatory.

Other Skills

  • Teamwork
  • Communication

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