Perm Clinical Trial Operations Associate – Homebased

Category: CTA
Job #: 10674
Location: Anywhere US (Homebased)
Job Type: Perm
Therapeutics: No Specific TA Required

One of our Sponsor Partners is looking for at least two Clinical Trial Operations Associates. 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 sponsor sites while also supervising assigned sites’ regulatory operations.

Job Responsibilities:
  • Perform regulatory start-up activities according to sponsor SOPs as well as relevant regulations and guidelines.
  • Serve as site and/or CRO regulatory contact.
  • Provide regulatory related study updates to CRAs or trial project teams.
  • Coordinate and participate in the creation of site regulatory documents and packets.
  • Perform Essential Document quality control (QC) to ensure complete and accurate.
  • Monitor site level study activities to ensure regulatory compliance and provide recommendations as needed.
  • Responsible to prepare and submit central IRB documentation.
  • Provide support to central and local IRB/ECs during reviews.
  • Participate in gathering, interpreting, and disseminating IRB communication to support assigned studies.
  • Issue site communications such as site activation letters.
  • Oversee Trial Master File (TMF) creation and maintenance.
  • Contribute to TMF plan development.
  • Participate in TMF index creation, setup, filing, tracking and QC activities.
  • Perform Site Level TMF reviews and maintenance.
  • Participate in inspections and/or audits as needed.
  • Performs other work-related duties as assigned.
Job Qualifications:
  • Minimum 18 months of TMF management, operational project team support and/or study start-up experience with a Sponsor is required
  • Strong understanding of ICH, FDA, IRB/IEC and other applicable regulations and guidelines.
  • Bachelor's or Associate's degree or equivalent is preferred

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