Senior Clinical Trial Assistant (Toronto)

ICON Strategic Solutions; Ontario; On-site; CAD 50,000 - 70,000; Full time

Job summary

A leading company is seeking a Senior Clinical Trial Assistant to support clinical studies in Toronto. The role involves managing regulatory documents, coordinating study start-up activities, and ensuring compliance with local regulations. Ideal candidates will have clinical research experience and strong organizational skills.

Qualifications

• 1 to 2 years of clinical research experience.
• Understanding of ICH/GCP guidelines.

Responsibilities

• Responsible for study start-up activities and maintaining clinical documents.
• Coordinate entry and maintain local data into study management systems.
• Support responses to local audits and inspections.

Skills

Communication

Organizational Skills

Attention to Detail

Job description

Senior Clinical Trial Assistant (Toronto)

The Clinical Trial Associate will be responsible for setting up, tracking, and maintaining Clinical Site related documents. You will help manage and review regulatory documents as well as maintain the Local Study File. Assist with coordinating the distribution, retrieval, and review of regulatory documents required for the initiation, conduct, and close-out of clinical studies.

Performs the role of Clinical Trial Assistant (CTA) supporting the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution, and closing of clinical trials. Performs regulatory document review and approval, including site-specific Informed Consents. Ensures trial activities comply with GCO SOPs, policies, and local regulatory requirements. May contribute to process improvements, training, and mentoring of other CTA’s.

Responsibilities

• Responsible for study start-up activities, including creating site folders, collating, preparing, and maintaining (e)SIP documents, updating systems.
• Liaise with clinical sites to collect, review, and track feasibility questionnaires.
• Coordinate entry and maintain local data into study management systems (eClinical, CDSS/CDSS-R, SADMS, etc.), including setting up new studies in eClinical.
• Act as a back-up for other Supplier CTAs.
• Ensure collection, review, tracking, and provision of appropriate clinical documents to support regulatory submissions and IRB/IEC submissions, including preparation and submission of documents to committees.
• Track and maintain study supplies in the office and facilitate distribution to sites, including preparing and distributing Study File Binders, study drugs, and Site Initiation materials.
• Organize and participate in Investigator meetings and workshops as required within budget.
• Support responses to local audits and inspections.
• Process, reconcile, distribute, and track essential documents, submitting them to RIM/EPIC or local archive per SOPs.
• Process SIPs and forward to Regulatory/RIM within 5 business days of SIP approval, following eSIP process.
• Complete tracking documentation, including spreadsheets, study, and contract trackers.
• Order, process, and track Case Report Forms (CRF), following up on queries as needed.
• Manage local distribution of Investigator Brochure.
• Prepare and review site communication documents; facilitate mass mailings/faxes.
• Provide administrative support such as word processing, photocopying, faxing, filing, managing correspondence, and preparing presentations.
• Set up/maintain courier accounts and organize shipments (including frozen samples).
• Interact with Clinical Research Services Manager for project or study-related work.
• Support the execution of clinical studies and study start-up activities.
• Track study-related documents and manage logistics and document exchange between sites and sponsor.
• Contribute to department goals, drive continuous improvement, and promote operational excellence.
• Identify opportunities and best practices with partners to improve operational effectiveness.
• Lead CTA activities as required, including working with the Line Manager to complete delegated tasks, develop policies, and mentor new CTAs.

Requirements

• 1 to 2 years of clinical research experience.
• Experience with Trial Master File maintenance, Study Start-Up, REB submissions, and essential document review.
• Ability to operate various systems and databases.
• Site experience as a study coordinator, research assistant, or previous CTA with CRO/sponsor.
• Experience with IRB/REB submissions and local/regional regulatory requirements.
• Understanding of ICH/GCP guidelines.
• Ability to work independently, manage multiple trials, and prioritize effectively.
• Excellent communication skills and ability to collaborate with multiple teams.
• Strong attention to detail and organizational skills.
• Preferably located in the same time zone or able to work EST business hours.