This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Assistant based in Canada.
This role offers the opportunity to support the successful delivery of global clinical research studies within a collaborative and quality-focused environment.
You will play a key role in coordinating essential trial documentation, supporting study teams, and ensuring operational excellence throughout the clinical trial lifecycle.
The position provides exposure to sponsors, investigators, vendors, and cross-functional clinical teams while contributing to impactful healthcare research.
You will help maintain regulatory compliance, improve study organization, and support the execution of trials according to industry standards.
This opportunity is ideal for a detail-oriented professional who enjoys project coordination, documentation management, and working in a fast-paced research setting.
You will gain valuable experience in clinical operations while developing expertise in global trial management processes.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Assistant based in Canada.
This role offers the opportunity to support the successful delivery of global clinical research studies within a collaborative and quality-focused environment.
You will play a key role in coordinating essential trial documentation, supporting study teams, and ensuring operational excellence throughout the clinical trial lifecycle.
The position provides exposure to sponsors, investigators, vendors, and cross-functional clinical teams while contributing to impactful healthcare research.
You will help maintain regulatory compliance, improve study organization, and support the execution of trials according to industry standards.
This opportunity is ideal for a detail-oriented professional who enjoys project coordination, documentation management, and working in a fast-paced research setting.
You will gain valuable experience in clinical operations while developing expertise in global trial management processes.
Accountabilities:
- Collaborate with sponsors, investigative sites, vendors, and internal teams to support timely and high-quality clinical trial execution in accordance with ICH-GCP guidelines and applicable regulations.
- Prepare, organize, maintain, and archive essential clinical trial documentation within Trial Master Files (TMF) and Clinical Trial Management Systems (CTMS).
- Support qualification activities for clinical sites by compiling documentation and assisting with compliance reviews.
- Assist with regulatory submissions and documentation preparation for authorities and ethics committees.
- Manage investigator site documentation, essential document files, and inspection-ready records.
- Support site identification activities, feasibility questionnaires, and site selection processes.
- Contribute to the preparation of clinical operations materials, including site logs, newsletters, meeting documents, and study resources.
- Coordinate logistics for investigator meetings, client meetings, and internal team meetings.
- Manage shipment tracking for trial documentation, supplies, manuals, and study materials.
- Monitor compliance metrics related to study monitoring activities and follow up with relevant teams when required.
- Support distribution and tracking of safety-related documentation, including SUSAR notifications.
- Generate reports and summaries from clinical systems such as EDC and IWRS platforms to support project management activities.
- Maintain study portals, websites, newsletters, and other communication tools as needed.
- Track site progress, support invoice processing, and assist with investigator payment activities.
- Participate in the development and maintenance of standard operating procedures, training materials, and clinical operations guidelines.
- Support audit and inspection readiness activities conducted by internal teams, sponsors, or regulatory authorities.
- Bachelor’s degree in Life Sciences or a related field.
- Strong written and verbal communication skills with excellent attention to detail.
- Proficiency with Microsoft Office Suite and clinical documentation tools.
- Minimum of 1 year of administrative support experience preferred.
- Experience managing and maintaining electronic Trial Master Files (eTMF) is preferred.
- Knowledge of ICH-GCP guidelines and applicable clinical research regulations.
- Ability to coordinate effectively with internal teams, external vendors, sponsors, and clinical sites.
- Strong organizational skills with the ability to manage multiple projects and deadlines.
- Ability to work independently while contributing effectively within a collaborative team environment.
- Willingness to travel up to 5% of working hours.
- Competitive compensation package with an estimated salary range of $45,000 - $65,000.
- Comprehensive health benefits, including medical, dental, and vision coverage.
- Life and accidental death & dismemberment insurance.
- Short-term and long-term disability coverage.
- Tuition reimbursement and professional development support.
- Fitness reimbursement and employee assistance program (EAP).
- Pension plan and opportunities for performance-based bonuses.
- Generous paid time off and sick leave.
- Flexible work options, including remote work opportunities from within Canada.
The Clinical Trial Assistant will support clinical operations teams by coordinating administrative, regulatory, and documentation activities required for the successful execution of clinical trials. The role requires strong organization, attention to detail, and the ability to collaborate with multiple stakeholders while maintaining compliance with clinical research standards.
Requirements:
The ideal candidate is a highly organized and detail-oriented professional with experience supporting clinical research operations. They should have strong communication skills, an understanding of clinical trial regulations, and the ability to manage multiple priorities in a structured environment.