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In house Senior Clinical Research Associate

In-House Senior Clinical Research Associate Opportunity - Cambridge, MA

(1 to 2 Days of remote flexibility)

Position Summary:

A pharmaceutical company located in Cambridge, MA is looking for a In-House CRA to join their team. This position will be responsible for assisting with execution of clinical trials while ensuring that trials are conducted in compliance with protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs. The CRA will assist the Clinical Operations team in facilitating management of clinical trials to include the planning, execution and closeout of multiple outsourced trials at various stages of development. It will also include oversight of contract CROs and other clinical vendors, as well as various other clinical trial management tasks.

Responsibilities:

  • Support the development and design of eCRFs, including participating in the EDC and IXRS specification process and UAT.
  • Perform ongoing and final review of eTMF for completeness.
  • Facilitate and track site selection and startup activities including facilitation of clinical trial agreement process.
  • Assist with the preparation and review of key trial-related documentation including study protocols, Investigators brochures, eCRF design and completion guidelines, study plans, laboratory manuals, Informed Consent Forms, and other study-related documents.
  • Participate in creation and distribution of any sponsor specific study aides/materials and communications.
  • Establish, monitor, track and summarize key study metrics trends, including screening, enrollment, key site and data management metrics, monitoring reports and protocol deviations.
  • Participate and assist with internal study team meeting management including agenda's, presentation materials, meeting minutes and action items.

Requirements:

  • 4+ years of supporting or managing tasks within a pharmaceutical, biotech, or CRO setting
  • 3+ years of monitoring experience
  • Associates or Bachelor's degree and/or equivalent relative experience.
  • Oncology or rare disease experience would be preferred
  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines.

If you or a Clinical Research Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.

Thank you!

Sthree US is acting as an Employment Agency in relation to this vacancy.