Clinical Trial Assistant I

Accountabilities: As a Clinical Trial Assistant I, you will support clinical operations activities by coordinating documentation, tracking study progress, and assisting project teams throughout the clinical trial lifecycle. Your responsibilities will include:

Collaborating with study sponsors, investigational sites, vendors, and internal teams to support timely and compliant clinical trial execution.

Assisting with the preparation, review, organization, and submission of regulatory documents for authorities and ethics committees.

Supporting clinical site qualification activities, including documentation collection and review to ensure compliance with ICH-GCP guidelines and applicable regulations.

Setting up, maintaining, and archiving study documentation within Trial Master Files (TMF) and Clinical Trial Management Systems (CTMS).

Maintaining essential study documents and ensuring files are complete, organized, inspection-ready, and available throughout the study lifecycle.

Supporting site identification activities, feasibility questionnaires, site selection processes, and trial start-up activities.

Assisting with the development and maintenance of clinical operations documents, logs, newsletters, and study materials.

Coordinating meetings with investigators, clients, vendors, and internal teams, including logistics and documentation support.

Managing shipment and tracking of trial materials, site documents, manuals, and required supplies.

Monitoring compliance metrics, tracking deadlines, and supporting follow-up activities with clinical teams.

Supporting the distribution and tracking of safety information, including SUSAR documentation and acknowledgements.

Downloading and organizing reports from clinical systems to support project managers and clinical trial managers.

Maintaining study portals, websites, newsletters, and other communication platforms.

Preparing progress reports, supporting invoice processing, and assisting with site payment coordination.

Following departmental procedures, supporting SOP updates, and contributing to inspection and audit readiness activities.

Providing general operational support to clinical teams and assisting with additional clinical operations activities as needed.

Requirements:

The ideal candidate is a detail-oriented professional with strong organizational skills and an interest in clinical research operations. Required qualifications and experience include:

Bachelor’s degree in Life Sciences or a related field.

Strong written and verbal communication skills with the ability to collaborate effectively with multiple stakeholders.

Excellent computer skills and advanced proficiency with Microsoft Office applications.

Minimum of 1 year of administrative support experience preferred.

Experience managing and maintaining electronic Trial Master Files (eTMF) is an asset.

Knowledge of ICH-GCP guidelines and relevant clinical research regulations.

Strong organizational skills with the ability to manage multiple priorities and maintain accurate documentation.

High attention to detail and commitment to quality and compliance.

Ability to work effectively in a collaborative team environment.

Willingness and ability to travel up to 5% of working hours.

Benefits:

The role offers a comprehensive benefits package designed to support health, professional development, and long-term well-being, including:

Competitive salary range of approximately $45,000 - $65,000.

Medical, dental, and vision coverage.

Life and accidental death & dismemberment insurance.

Short-term and long-term disability coverage.

Pension plan and retirement support.

Performance-based bonus opportunities.

Generous paid time off and sick leave.

Tuition reimbursement and opportunities for professional growth.

Fitness reimbursement programs.

Employee Assistance Program (EAP).

Opportunities to develop clinical research expertise within a global healthcare environment.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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