Clinical Research Associate

4 weeks ago

South Portland, United States Abbott Laboratories Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of .
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

What You'll Do

  • Conduct monitoring visits and activities in accordance with FDA Code of Federal Regulations, GCP guidelines, departmental SOPs, Work Instructions and the Clinical Monitoring Plan
  • Serve as primary site contact; establish and maintain regular communication with clinical sites
  • Conduct Site-Qualification, Initiation, Interim and Closeout visits to include document review for accurate data recording, source data verification to protocol adherence and governing regulations
  • Assist with distribution, collection, and tracking of regulatory documents for site compliance and audit readiness
  • Prepare and maintain monitoring visit reports and site communication documentation
  • Identify and resolve routine site issues, protocol deviations, queries, study discrepancies and collects missing or incomplete information
  • Assist with sample tracking, supply shipments and other diagnostic requirements
  • Use of EDC and other electronic tools to review monitor listings and queries
  • Review of Investigator Site Files and Sponsor Study Files
  • Additional project and tasks as determined by department and organizational needs
  • Travel may be approximately 10%

Technical skills/Knowledge/Abilities

  • Working knowledge of clinical trial practices and regulations
  • Working knowledge of clinical trial databases
  • Proficient computer skills including Microsoft Office Suite

Required Qualifications

  • Minimum BA or BS and
  • 2 years of related clinical trial monitoring experience

Preferred Qualifications

  • on-site monitoring experience of IVD clinical studies is preferred



The base pay for this position is $48,000.00 â $96,000.00. In specific locations, the pay range may vary from the range posted.

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