Clinical Trial Associate

POSTED ON 1/22/2021 AVAILABLE BEFORE 7/21/2021
Repertoire Immune Medicines Hired Organization Address Cambridge, MA Full Time

Job Posting for Clinical Trial Associate at Repertoire Immune Medicines

About Us:
We are Repertoire Immune Medicines – a Flagship Pioneering company working to unleash the remarkable power of the human immune system. We seek to harness the intrinsic ability of T cells to prevent and cure disease. Our mission is a challenging one, requiring a complex and multi-dimensional approach that integrates cutting-edge biology and sophisticated, novel technologies. We stand ready to meet this challenge with our unique platforms, world-class team and unparalleled network of researchers, clinicians, academics, and entrepreneurs.

Position overview

The CTA will work across the PRIME 15 and PRIME 12 programs and support the Clinical Program Leads and other team members in the execution of the Phase 1/2 studies.  This position will report to the Associate Director, Clinical Operations.

Specific responsibilities:

  • Work with clinical operations team(s) to review and QC clinical documents (Protocols, Informed Consent Forms, study plans and related documents).
  • Participate in the preparation and maintenance of study manuals, site tools, templates, source documents, guidelines, etc.
  • Support the clinical operations team(s) in the overall management of studies, including planning, execution, and closeout of clinical trials
  • Maintain the electronic Trial Master File (TMF) by collecting and QCing essential documents from clinical sites and vendors, uploading documents to the TMF and managing the TMF vendor
  • Track the collection and shipment of study samples
  • Coordinate the distribution of clinical trial supplies and study product
  • Facilitate shipment requests to third party vendors and reconcile sample manifests
  • Set up purchase orders for external vendors and track invoices and payments for vendors and sites
  • Attend internal meetings and support the Clinical Program Lead with meeting logistics (e.g. scheduling, agenda preparation, draft meeting minutes, and collating materials for meetings).
  • Manage the execution of a screening protocol that is being used to identify patients for treatment protocols, including interacting with sites to monitor enrollment, managing sample shipments to the central lab and tracking results to ensure the seamless transition of patients into treatment protocols
  • Effectively and efficiently interact with internal, clinical site(s) and vendor personnel

Minimum Education/Experience

  • Bachelor’s degree required
  • 1 - 2 years of experience working in academic study center, pharmaceutical/biotechnology or CRO organization.

Required Qualifications

  • Proficient in computer technology used in an office environment (Microsoft Word, Excel and PowerPoint).
  • Excellent communication skills
  • Ability to work in a flexible, matrix environment

 

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