Regulatory Affairs Coordinator

23 hours ago


Fatih, Istanbul, Turkey Syneos Health, Inc. Full time
Regulatory Affairs Coordinator

Syneos Health is committed to building a diverse, inclusive and authentic workplace where everyone feels like they belong. If your past experience doesn't align perfectly, we encourage you to apply anyway.

About the Role

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Site Activation department, you will be responsible for ensuring continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.

Responsibilities

  • Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.
  • May be involved in vendor management.
  • Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI), keeping training records updated accordingly and ensuring timesheet compliance.
  • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.

Requirements

  • Bachelor's Degree, preferably in a science field.
  • Minimum of 3.5 years' experience as a country start-up specialist.
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Good understanding of clinical protocols and associated study specifications.
  • Excellent understanding of clinical trial start-up processes.
  • Project management experience in a fast-paced environment is an advantage.


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