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Senior Clinical Research Associate (remote)

Company: Bongene Search
Location: Washington
Posted on: January 16, 2022

Job Description:

Bongene Search is biotech, pharmaceutical, and medical staffing agency that believes talent lies at the heart of all great companies. As such, the team at Bongene Search is dedicated to helping our clients around the globe create the most talented team of biopharma professionals. Whether it is a large publicly-traded company or a biotech start-up, our medical, pharmaceutical, and biotech recruiting agency will create a tailor-made search process that delivers the perfect fit for the role. We represent the following opportunity from our client.
Senior Clinical Research Associate
RESPONSIBILITIES

  • Lead small groups, interact well with teams yet also be independent contributors
  • Onboard/train new CRA's
  • Deal with conflicts and resolutions, representing the company externally
  • Take responsibility for a number of studies/sites and provide updates to the management
  • Understand the company's products (cartridges/samples/analyzers)
  • Understand preanalytical sample handling issues and be able to run various cartridges
  • Support the creation of the protocol and all of the associated study documentation (brochures, ICFs, CRFs, IRB submission packages, etc)
  • Identify and prequalify/approve sites where the studies will be carried out
  • Support the creation of study-specific electronic data collection fields and system elements (additionally be able to do user acceptance testing)
  • Support the creation of the clinical trial master file folders and system elements
  • Work with sites to ensure all of the documentation from sites is collected prior to starting the study and is also filed
  • Support preparation and execution for study site initiations, collecting documents, generating training modules
  • Understand and be able to carry out data/site monitoring both remotely and onsite
  • Support data verification and reviews to prepare collected data for analyses
  • Lead and work with sites for closeout of the studies
  • Lead and carry out post-study tasks regarding reports, trial master file documents, financial documentation, etc.
  • Ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions
    QUALIFICATIONS
    • 7+ years of relevant work experience or exposure to a technical/clinical environment, laboratory instrumentation, and/or medical diagnostic testing
    • Bachelor's degree or equivalent experience required; prefer a background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy, or related field of study)
    • Knowledge of lab practices or point of care testing environments, regulations and standards affecting medical diagnostics, lab practices, familiarity with statistics, and statistical software (desired)
    • Knowledge of Good Manufacturing Practice 21 CFR Part 820; International Harmonized /Committee Good Clinical Practices, IHC/GCP

Keywords: Bongene Search, Washington DC , Senior Clinical Research Associate (remote), Healthcare , Washington, DC

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