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Associate Clinical Research Iii

6+ years
$83,600.00 – $167,200.00.
10 Dec. 4, 2024
Job Description
Job Type: Full Time Education: B.Sc./ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Clinical Research III

Location: Alameda, California, USA
Category: Medical and Clinical Affairs


About Abbott

Abbott is a global healthcare leader, committed to creating breakthrough science to improve lives. With a diverse portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott operates in over 160 countries, empowering people at all stages of life.


Position Overview

The Associate Clinical Research III plays a critical role in executing and managing clinical studies from inception to completion. The role includes study planning, monitoring, and compliance, ensuring delivery within timelines and quality standards. This position contributes to product development and regulatory submissions while adhering to Good Clinical Practices (GCPs) and regulatory guidelines.


Key Responsibilities

  • Design, execute, and monitor clinical studies, ensuring adherence to protocols and regulations.
  • Support external studies, including PMA and outcome studies, by assisting with design, training, and monitoring.
  • Participate in cross-functional product development activities.
  • Perform study site visits (SQV, SIV, IMV, COV) and generate monitoring reports.
  • Oversee study start-up activities, including device shipment and accountability.
  • Maintain and audit the Trial Master File (TMF) for inspection readiness.
  • Review clinical data for accuracy and escalate issues when necessary.
  • Assist with planning and execution of investigator site training, study meetings, and data reviews for regulatory submissions.
  • Support preparation for FDA inquiries and audits in collaboration with RA/QA teams.

Qualifications

  • Education: Bachelor’s degree in life sciences.
  • Experience:
    • 6+ years as a CRA or CRC, or a combination of relevant education and experience.
    • 3+ years in site monitoring, clinical trial practices, and regulations.
    • Background in medical device, in-vitro diagnostics, or pharmaceutical clinical studies.
  • Skills:
    • Solid understanding of clinical trial processes, data management systems, and regulatory requirements.
    • Proven teamwork, communication, and interpersonal skills.
    • Experience with study design, data analysis, and reporting.

Why Join Abbott?

  • Career Development: Work in a global organization with opportunities to grow and learn.
  • Comprehensive Benefits: Free medical coverage, excellent retirement plans, tuition reimbursement, and more.
  • Recognition: Abbott is celebrated as a great place to work for diversity, working mothers, and scientists.

Compensation

  • Base pay range: $83,600 – $167,200 (may vary by location).

Apply Now to make an impact in healthcare innovation while advancing your career with Abbott.

For more information on benefits, visit www.abbottbenefits.com.