Clinical Research Associate III

4 weeks ago

Alameda, California, United States Abbott Full time
About Abbott

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.

Job Description

We are seeking a highly skilled and motivated Associate Clinical Research III to join our team. As a key member of our clinical operations team, you will be responsible for the design, execution, and monitoring of internal clinical studies, as well as participating in the design, training, and monitoring of Abbott-sponsored external clinical studies.

Key Responsibilities
  • Design, execute, and monitor internal clinical studies
  • Participate in the design, training, and monitoring of Abbott-sponsored external clinical studies
  • Identify and qualify external clinical sites
  • Develop and maintain standard operating procedures
  • Participate in cross-functional team activities for product development
  • Effectively communicate study outcomes to cross-functional teams
  • Perform study site visits, ensuring compliance with study protocol, GCPs, ICH guidelines, and regulatory requirements
  • Participate in study start-up activities
  • Ensure shipment of study devices and supplies to clinical sites and perform study device accountability
  • Assist senior staff in planning study conduct, designing case report forms, selecting and training investigator sites, planning and running study meetings, evaluating, selecting, and training new study investigators
  • Maintain and audit Trial Master File to ensure inspection readiness
  • Review clinical data listings for completeness and accuracy, and escalate issues to Clinical Operations Manager as needed
  • Proactively and effectively communicate study status to management
  • Ensure quality delivery of study deliverables within agreed budgets and timelines
  • Participate in interim and final reviews of study data in preparation of regulatory submissions
  • Prepare all applicable documents required for the conduct of the study
Requirements
  • BS degree in life sciences with six years of experience as a CRA or CRC or combination of appropriate education and experiences required
  • Must have 3+ years of relevant experience in site monitoring, clinical trial practices, and regulations
  • Experience in conducting medical device and/or in-vitro diagnostics studies
  • Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills
  • Solid understanding and demonstrated experience of the clinical trial process
What We Offer

At Abbott, we offer a competitive salary range of $83,600.00 – $167,200.00, depending on location. We also provide a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits. Join our team and take the first step towards a rewarding career in clinical research

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