USA Remote (Global)

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

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 Clinical Trial ManagementRegulatory ComplianceICH-GCP GuidelinesStudy DocumentationStakeholder CommunicationSite ManagementProtocol AdherenceClinical Data ReviewProject CoordinationSOPsTMF ManagementVendor Oversight
About company
Syneos Health
A leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Operates in clinical development with a model centered on the customer and patient.
All jobs at Syneos Health Visit website
Job Details
Category other
Posted 9 months ago