Clinical Research Associate

2+ years

$55,200/yr - $110,400/yr

San Diego

12 May 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate

Location: Flexible

About Abbott:
Abbott is a global healthcare leader dedicated to improving people's health through breakthrough science. With a diverse portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott serves individuals in over 160 countries.

Working at Abbott:
At Abbott, employees have the opportunity to do meaningful work, grow professionally, care for themselves and their families, and be their authentic selves. Benefits include career development opportunities, free medical coverage through the Health Investment Plan (HIP) PPO, a robust retirement savings plan, tuition reimbursement, and access to the Freedom 2 Save student debt program and FreeU education benefit. Abbott is consistently recognized as a great place to work globally and has received numerous accolades for its commitment to diversity and inclusion.

Responsibilities:

Conduct monitoring visits in compliance with FDA regulations, GCP guidelines, and departmental procedures.
Serve as the primary contact for clinical sites and maintain regular communication.
Perform Site-Qualification, Initiation, Interim, and Closeout visits, ensuring accurate data recording and protocol adherence.
Assist with regulatory document distribution, collection, and tracking for site compliance.
Prepare monitoring visit reports and maintain site communication documentation.
Identify and resolve site issues, protocol deviations, and study discrepancies.
Assist with sample tracking, supply shipments, and other diagnostic requirements.
Utilize EDC and other electronic tools for data review and monitoring.
Review Investigator Site Files and Sponsor Study Files.
Perform additional tasks as assigned by department and organizational needs.
Travel may be required up to approximately 10%.

Technical Skills/Knowledge/Abilities:

Working knowledge of clinical trial practices and regulations.
Familiarity with clinical trial databases.
Proficiency in Microsoft Office Suite.

Required Qualifications:

Bachelor's degree or equivalent.
Minimum of 2 years of related clinical trial monitoring experience.

Preferred Qualifications:

Experience in on-site monitoring of IVD clinical studies is preferred.

Base Salary:
$55,200/yr - $110,400/yr (may vary based on location)

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Clinical Research Associate

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