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Clinical Trials Specialist

2 months ago


Maidenhead, Windsor and Maidenhead, United Kingdom MAI Fortrea Development Limited Full time

**Job Summary**

MAI Fortrea Development Limited is seeking a highly skilled and experienced Clinical Trial Administrator to join our expanding team in London. As a key member of our team, you will be responsible for providing administrative support to our clinical trials team, ensuring the smooth execution of our clinical trials.

**Key Responsibilities:**

  • Act as a liaison between project teams and study sites, ensuring effective communication and coordination.
  • Perform comprehensive review of Case Report Forms (CRFs) against established data review guidelines, utilizing management systems to ensure accuracy and compliance.
  • Assist with the management of study supplies, including organizing shipments and ensuring timely delivery.
  • Develop, update, track, and maintain study-specific trial management files, tools, and systems, ensuring seamless data management.
  • Provide administrative support to local project team members, including preparing payments to investigators, correspondence with clients, and organization of investigators' meetings.
  • Coordinate meetings with clients, investigators, and project team members, including taking minutes and ensuring accurate documentation.
  • Ensure compliance with regulatory requirements, including FDA, ICH, and GCP regulations, in all aspects of daily work.
  • Contribute to the development of Monitoring Conventions, as assigned.
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities, ensuring timely and accurate communication.

**Requirements:**

  • A minimum of 12 months of Clinical Research Administration experience from a CRO or Pharma company.
  • Residency in commuting distance of Central London.
  • Basic understanding of biology and biological processes.
  • Excellent organizational and time management skills.

**About Us:**

MAI Fortrea Development Limited is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe.