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About the Role

The Clinical Trial Assistant supports the clinical trial team in delivering clinical studies, ensuring operational execution within timelines, budget, and quality standards from protocol development through study close-out and archiving. The role provides technical, administrative, and logistical support for efficient trial execution in compliance with regulations.

Responsibilities

• Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS).
• Ensure eTMF and CTMS information is updated during the study per ICH/GCP and sponsor SOPs.
• Create and maintain communication platforms for the study team.
• Control systems access for assigned studies, including IxRS, EDC, CTs, and eTMF.
• Support clinical trial registration and disclosure on websites per regulatory requirements.
• Manage overall TMF status, guide study team members on document transfer and archival, and lead quality checks per the TMF plan.
• Assist in drafting the TMF plan.
• Facilitate finance-related activities, including sign-off, IO and PO setup, invoice processing, and tracking accruals and budget for sites and vendors.
• Support oversight of monitoring visit report review, including updating trackers and overseeing review metrics.
• May support data oversight and reconciliation efforts for vendor systems, SAEs, and protocol deviations.
• Coordinate and track clinical supplies.
• Arrange internal and external meetings and take meeting minutes as needed.
• Compile and maintain clinical trial related lists and logs.
• Draft and distribute newsletters and communications materials.
• Complete delegated tasks during audits and inspections by regulatory authorities.

Requirements

• High school or GED with four years relevant experience.
• At least 1 year experience as a CTA, CRC, or other role in clinical trials.
• Oncology experience is a significant advantage.
• Proven organizational and presentation skills.
• Ability to manage multiple tasks with meticulous attention to detail.
• Quick learner and team player.
• Excellent written and verbal communication skills.
• Computer proficiency in Microsoft Word, Excel, PowerPoint and Outlook.
• Good knowledge of ICH/GCP.
• Must have the legal right to work in the country where the role is based.

Skills

• eTMF system management
• CTMS management
• ICH/GCP compliance
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Outlook

Location

• San Francisco, CA

Work Type

• Hybrid
• On-site (3-4 days/week)

Experience Level

• 1+ year experience

Education Level

• High school or GED
• Bachelor's degree or above (Life Sciences preferred)
• Certification in a related health profession (i.e. nursing, medical or laboratory technology)

Salary/Compensations

• $56,704.00-$70,880.00

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes
• Medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities

About the Company

• ICON is a global healthcare intelligence and clinical research organisation.
• ICON is united by a mission to bring new medicines and treatments to patients faster.
• ICON is a values-driven organisation where integrity, collaboration, agility, and inclusion are central to its operations.

Equal Opportunity

• ICON is an equal opportunity employer.
• We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• Reasonable accommodations during the recruitment process are available upon request.