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Clinical Research Associate

2 months ago

Dubai, Dubai, United Arab Emirates Actalent Full time
About the Role

As a Clinical Research Associate at Actalent, you will play a critical role in ensuring the success of clinical trials by ensuring compliance with regulatory requirements and protocols.

Key Responsibilities
  • Site Qualification and Monitoring: Perform site qualification, initiation, interim, and close-out monitoring visits to ensure compliance with clinical trial protocols and regulations.
  • Regulatory Compliance: Ensure that all clinical trial activities are conducted in accordance with ICH GCP guidance and FDA regulations.
  • Source Data Verification and Study File Review: Conduct monitoring visits at sites to perform source data verification and study file review, and address identified issues directly with site staff.
  • Issue Management: Manage complex issues with minimal support, analyze trends in identified issues, and write visit follow-up reports with minimal oversight and guidance.
  • Communication and Training: Communicate effectively with sites to resolve issues, provide clear and technically accurate information, and participate in training junior CRAs on moderately complex concepts, processes, and tasks.
  • Project Management: Manage moderately complex projects as assigned under the direction of the Clinical Project Manager.
  • Tool Development: Create and/or contribute to the development of monitoring/audit tools and materials, such as project-specific work instructions, training materials, and newsletters.
  • Protocol Development: May participate in the development of study protocols, case report forms, and clinical monitoring plans, and provide expert input.
  • Documentation and Reporting: Author and review drafts of project-specific forms, instruction manuals, and CRF completion guidelines.
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.

Our Commitment to Diversity, Equity, and Inclusion

We believe that diversity and inclusion are essential to our success. We are committed to creating a culture of care, engagement, and recognition, and to ensuring growth opportunities for our people. We achieve this 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