Clinical Research Associate

4 weeks ago

Dubai, Dubai, United Arab Emirates Actalent Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Actalent. As a Clinical Research Associate, you will be responsible for ensuring compliance with clinical trial protocols and regulations, conducting monitoring visits, and managing complex issues with minimal support.

Key Responsibilities
  • Perform site qualification, initiation, interim, and close-out monitoring visits to ensure compliance with clinical trial protocols and regulations.
  • Conduct monitoring visits at sites to perform source data verification and study file review, and address identified issues directly with site staff.
  • Manage complex issues with minimal support, analyzing trends and writing visit follow-up reports with minimal oversight and guidance.
  • Communicate effectively with sites to resolve issues, providing clear and technically accurate information both orally and in writing.
  • Participate in training junior CRAs on moderately complex concepts, processes, and tasks.
  • Manage moderately complex projects assigned under the direction of the Clinical Project Manager.
  • Create and/or contribute to the development of monitoring/audit tools and materials, such as project-specific work instructions, training materials, and newsletters.
  • May participate in the development of study protocols, case report forms, and clinical monitoring plans, providing expert input.
  • Author and review drafts of project-specific forms, instruction manuals, and CRF completion guidelines.
Requirements
  • Clinical research study processes, study design, and/or protocol management.
  • Clinical trial monitoring procedures and clinical data reporting processes.
  • ICH GCP guidance and FDA regulations.
  • Medical terminology and anatomy/physiology.
  • Microsoft Suite of software products.
  • Intermediate project management, training, and conflict resolution skills.
  • Perform tasks requiring excellent attention to detail.
  • Manage multiple deadlines and priorities while ensuring quality and timeliness.
  • Work effectively and efficiently in a remote environment.
  • Travel up to 70% of the time (domestic and international).
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent.
  • Maintaining an inclusive environment through persistent self-reflection.
  • Building a culture of care, engagement, and recognition with clear outcomes.
  • Ensuring growth opportunities for our people.

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