Clinical Research Associate I

Abbott LaboratoriesAlameda, CA
$73,900 - $116,000Onsite

About The Position

Supports clinical trial start-up activities, including investigator debarment checks, regulatory document collection, study file preparation, site qualification visits, and site selection support. This position will be based in our Alameda, CA office.

Requirements

  • BS degree in life sciences preferred, with two years of experience as a CRC/CTA or combination of appropriate education and experience.
  • Experience in conducting medical device studies preferred, pharmaceutical background may also be considered.
  • Must be able to travel 30-40%

Nice To Haves

  • Demonstrated excellence in teamwork, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
  • Working knowledge of GCP, Clinical and Regulatory Affairs.
  • Flexibility in daily activities.
  • Proficient with Microsoft Suite

Responsibilities

  • Participate in study start up activities, to include but not limited to, conducting investigator debarment checks, collection of regulatory documents and preparing the study files.
  • Conduct Site Qualification Visits (SQV) and reporting to ensure study staff and research site are adequate to perform ADC trials.
  • Assist with shipment of study devices and supplies to clinical sites and maintain communication with the device group as required.
  • Responsible for assisting senior study startup staff during site selection
  • Maintain and audit Trial Master File and upload to Veeva Vault to ensure inspection readiness.
  • Proactively and effectively communicate the status of clinical trial start up to management.
  • Support regulatory submissions
  • Perform any other duties as assigned by management.

Benefits

  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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