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Senior Cra- Ca

3-4 years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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:

Senior CRA – California (CA)


Location:

United States (Remote – California region preferred)


Job ID:

2025-118288


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Melissa Benner
Options: View other roles or send a direct message through the platform


Job Description:

As a Senior Clinical Research Associate (CRA), you will oversee and manage clinical trial sites to ensure compliance, data integrity, and patient safety. Your responsibilities span from pre-study visits to close-out, including protocol adherence, regulatory compliance, and mentoring junior CRAs. You will support clinical research operations remotely and on-site across California.


Key Responsibilities:

  • Monitor progress of clinical studies at sites or remotely

  • Ensure trials are conducted in compliance with protocols, SOPs, ICH-GCP, and regulatory guidelines

  • Maintain high-quality Monitoring Visit Reports and follow-ups

  • Confirm subject safety and integrity of collected data

  • Identify and address site-level scientific misconduct or protocol deviations

  • Manage IP (Investigational Product) accountability

  • Support team with CTM tasks, process improvements, and training

  • Lead observation visits and participate in investigator/client meetings

  • Mentor new CRAs and help develop trial tools/documents

  • Utilize CTMS, EDC, IVRS/IWRS systems efficiently


Requirements:

  • Education:

    • Bachelor’s degree or equivalent in science/health-related field OR licensed healthcare professional (e.g., RN)

  • Experience:

    • At least 4 years in clinical trial support with 3 years of on-site CRA monitoring

    • Strong knowledge of ICH-GCP, clinical trial components (PSSV to COV)

    • Proven experience with fast-paced trial environments and database lock timelines

    • Fluent in English and local language

    • Proficient in Microsoft Office and clinical systems

    • Ability to travel (~10 site visits/month)


Benefits:

  • Competitive salary and annual leave

  • Health insurance options tailored to individual and family needs

  • Retirement planning with strong savings benefits

  • Global 24/7 Employee Assistance Program (TELUS Health)

  • Life assurance

  • Country-specific optional perks (childcare vouchers, gym memberships, travel discounts, etc.)
    🔗
    Explore ICON Benefits


Inclusion & Accessibility:

ICON is an equal opportunity employer that values diversity and is committed to a harassment-free workplace.
🔗
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