CRA II - Romania - FSP Dedicated

Position Overview

• Location Type: Onsite
• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)

Job Description: At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Keys to Success:

• Education: University degree in a life-sciences field
• Experience: Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation (at least for 1 year)
• Knowledge, Skills, Abilities:
  • Demonstrated understanding of ICH-GCP, EU and FDA requirements
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Exceptional communication, collaboration, organizational, and time management skills
  • Fluency in Romanian and English languages
• Availability: Availability for travel (at least 50% from the working time/month)
• Residency: Preferable Bucharest and Cluj-Napoca

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring process.
• Conduct monitoring activities independently.

Requirements

• Independent on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation (at least 1 year).
• University degree in a life-sciences field.
• Fluency in Romanian and English languages.
• Understanding of ICH-GCP, EU and FDA requirements.
• Medical/therapeutic area knowledge and medical terminology understanding.
• Excellent communication, collaboration, organizational, and time management skills.

Application Instructions

• Note: Specific application instructions are not provided in the original job description.