Job Title:
Clinical Study Associate – Medical Device (Hybrid, Irvine, CA)
Location:
Hybrid – Irvine, CA (Lake Forest, Santa Ana)
Job ID:
2025-118369
Department:
Clinical Trial Support – ICON Strategic Solutions
Job Type:
Full-Time, Hybrid
Application Contact:
Name: Monica Hawkins
Options: View other roles or send a message via the application platform
Job Description:
The Clinical Study Associate will assist with processing, tracking, and maintaining clinical study documents and managing the Trial Master File (TMF) for clinical projects. This role provides administrative support to clinical study staff and project managers within the clinical studies, ensuring compliance with regulatory guidelines, departmental instructions, and client SOPs.
Key Responsibilities:
Maintain and track study activities within CTMS in collaboration with the study team
Create and distribute regulatory binders
Ensure the completeness of the Trial Master File (TMF) for assigned clinical studies
Assist in creating, ordering, and distributing study supplies to sites (e.g., protocols, DVDs)
Track device inventory and ordering when applicable
Support safety documentation and participate in safety committee meetings
Provide logistics support for Investigator meetings and expert panel meetings
Generate and maintain system reports related to study progress
Required Qualifications:
Location: Must be based in the Irvine, CA area (Hybrid work structure)
Degree: Bachelor’s Degree in a relevant field
Experience:
At least 1 year of administrative support experience
Clinical research experience preferred
Clinical/medical background a plus
Proficient in Microsoft Office (Excel, Word, PowerPoint)
Pay Range: $45,864.00 – $57,330.00 per year (Compensation may vary based on experience, education, and location)
What ICON Offers:
Competitive salary and performance rewards
Health insurance and retirement planning
Global Employee Assistance Program (TELUS Health) for 24/7 support
Paid annual leave, life assurance, and other benefits
Flexible country-specific optional benefits like childcare vouchers, gym memberships, and health assessments
🔗 Explore ICON Benefits
Diversity & Inclusion Commitment:
ICON is committed to creating an inclusive and accessible workplace, ensuring equal opportunities for all candidates.
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