Remote (Global) Full-time

Syneos Health is hiring a Clin Ops Specialist/CTA (home based)

About the Role

Syneos Health is hiring a Clinical Operations Specialist/Clinical Trial Assistant (CTA) for a home-based role. You will be responsible for supporting clinical monitoring staff and ensuring site compliance with study protocols and procedures. Syneos Health is passionate about developing our people and building a place where everyone feels they belong.

What You'll Do

  • Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
  • Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies.
  • Communicate with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
  • Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
  • Prepare and maintain site manuals, reference tools and other documents.
  • Maintain, update, and input clinical tracking information into databases.
  • Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
  • Manage shared mailbox, process site requests and route correspondence appropriately.
  • Coordinate the ordering, packaging, shipping and tracking of site supplies and materials.
  • Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items.
  • May handle receipt, tracking and disposition of Case Report Forms and Queries.
  • Maintain overall awareness in the field of clinical research by completing all necessary and assigned training.

What We're Looking For

  • High School diploma or equivalent
  • Good communication and interpersonal skills
  • Ability to embrace new technologies

Work Mode

This is a home-based (remote) position.

Syneos Health is an equal opportunity employer.

Required Skills
Clinical Trial ManagementRegulatory ComplianceICH-GCP GuidelinesStudy DocumentationStakeholder CommunicationSite ManagementProtocol AdherenceClinical Data ReviewProject CoordinationSOPsTMF ManagementVendor Oversight
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About company
Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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Job Details
Category other
Posted 7 months ago