Study Start-up Specialist (US)

Category: CTA
Job #: 10638
Location: Anywhere US
Job Type: Perm
Rate / Salary Range: $50,000 - $60,000

One of our Sponsor Partners is looking for a Study Start-up Specialist. This is a great opportunity to get in with a growing sponsor in an important supporting role of the clinical team. This is a permanent position, and the main role of this position 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:
  • Bachelor's or Associate's degree or equivalent is preferred
  • 18 months of study start-up experience with a Sponsor is required

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