Clinical Trial Assistant I

About the Role

This position supports clinical research studies within a dynamic healthcare environment in Canada. You will collaborate closely with clinical operations teams, study sponsors, investigational sites, and vendors to facilitate efficient and compliant clinical trial delivery. This role centers on maintaining critical documentation, coordinating trial activities, and supporting clinical operations to ensure adherence to regulatory standards.

Working alongside experienced professionals, you will contribute to study compliance, operational precision, and timely achievement of clinical milestones, gaining valuable experience in pharmaceutical, biotechnology, and medical device research.

Key Responsibilities

• Coordinate with study sponsors, investigational sites, vendors, and internal teams to support timely and compliant clinical trial processes.
• Assist in preparing, reviewing, organizing, and submitting regulatory documents to authorities and ethics committees.
• Support clinical site qualification activities by collecting and reviewing documentation to ensure compliance with ICH-GCP and applicable regulations.
• Manage, maintain, and archive documentation within Trial Master Files (TMF) and Clinical Trial Management Systems (CTMS).
• Ensure essential study files are complete, organized, inspection-ready, and accessible throughout the project.
• Support site identification, feasibility questionnaires, site selection, and trial start-up tasks.
• Assist in developing and maintaining clinical operations documents, logs, newsletters, and study materials.
• Coordinate meetings with various stakeholders including investigators, clients, and vendors, providing logistical and documentation support.
• Manage shipping and tracking of trial materials, manuals, site documents, and supplies.
• Monitor compliance metrics, track deadlines, and assist in follow-up activities with clinical teams.
• Support distribution and tracking of safety information such as SUSAR documentation and acknowledgements.
• Download and organize clinical system reports to aid project and trial managers.
• Maintain study portals, websites, newsletters, and communication platforms.
• Prepare progress reports, support invoice processing, and assist with site payment coordination.
• Adhere to departmental procedures, contribute to SOP updates, and support inspection and audit preparedness.
• Provide general operational support to clinical teams and assist with additional activities as required.

Candidate Requirements

• Bachelor’s degree in Life Sciences or a related discipline.
• Strong verbal and written communication skills to effectively liaise with multiple stakeholders.
• Proficiency with Microsoft Office applications and solid computer skills.
• Preferably at least 1 year of experience in administrative support roles.
• Experience with managing electronic Trial Master Files (eTMF) is advantageous.
• Knowledge of ICH-GCP guidelines and relevant clinical research regulations.
• Excellent organizational abilities to handle multiple priorities with accuracy and compliance.
• High attention to detail and dedication to quality.
• Ability to work collaboratively within a team setting.
• Willingness to travel up to 5% of working hours.

Compensation and Benefits

• Competitive annual salary range between 45000 and 65000 CAD.
• Comprehensive medical, dental, and vision insurance coverage.
• Life insurance plus accidental death and dismemberment benefits.
• Short-term and long-term disability insurance plans.
• Participation in pension and retirement support programs.
• Performance-based bonus opportunities.
• Generous paid leave including vacation and sick days.
• Tuition reimbursement and avenues for professional development.
• Fitness reimbursement programs to support wellbeing.
• Access to Employee Assistance Programs (EAP).
• Opportunities to cultivate expertise in clinical research in a global healthcare setting.

Additional Information

This position is offered through a partner company that manages application processing and subsequent recruitment stages. The selection and further procedures are handled by the employing organization. Applicants' data will be processed in compliance with data protection laws and may involve AI-assisted application review to enhance fairness and efficiency, though final hiring decisions remain human-led.