Study Start-up Specialist (US)

Category: CTA
Job #: 10655
Location: Anywhere US
Job Type: Perm
Rate / Salary Range: $50,000 - $60,000

One of our Sponsor Partners is looking for at least two Study Start-up Specialists. This is a great opportunity to get in with a growing sponsor in an important supporting role of the clinical team. These are permanent positions, and the main role of these positions will be to coordinate the preparation and activation of the site while also supervising its regulatory operations.

Job Responsibilities:
  • Perform Regulatory Start-up according to applicable regulations, SOPs, and guidelines
  • Serve as site/CRO regulatory contact and provide regulatory-related study updates to CRAs or trial project teams
  • Prepare site regulatory documents and packets
  • Perform essential document QC for completeness and accuracy
  • Monitor site level study activities to ensure regulatory compliance and provide recommendations as needed
  • Prepare and Submit central IRB documentation and provide support to central and local IRB/ECs during reviews
  • Contribute to the collection, interpretation, and dissemination of accurate IRB communication to support assigned studies and wider company, as required
  • Issue site communications such as site activation letters
  • Oversee study, country, and site level TMF creation and maintenance
  • Perform Site Level TMF reviews
  • Ensure accurate completion and maintenance of TMF and tracking tools with project specific information
  • Provide guidance and serve as a resource to co-workers
  • Participate in internal or external audits and regulatory authority inspections as needed
  • Performs other work-related duties as assigned
Job Qualifications:
  • 18 months of TMF management and/or study start-up experience with a Sponsor is required
  • Bachelor's or Associate's degree or equivalent is preferred

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