Senior Cra- Ca

3-4 years

Not Disclosed

California United States

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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Senior Cra- Ca

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