Clinical Trial Assistant I

Everest Clinical Research Corporation; Markham; On-site; CAD 45,000 - 65,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Pension plan

Tuition reimbursement

Fitness reimbursement

EAP

Paid time off

Job summary

Everest Clinical Research seeks a Clinical Trial Assistant for our Toronto/Markham, Ontario, on-site location or remote from anywhere in Canada under our Work from Home policy. You will support Sponsors, investigational sites, and internal teams to ensure timely, compliant clinical trials in line with ICH-GCP.

The role involves TMF/CTMS maintenance, regulatory submissions, site qualification support, meeting coordination, document tracking, and collaborative SOP development.

Qualifications

• Excellent verbal and written communication; strong computer skills.
• Proficient in Microsoft Office suite (Word, Excel, PowerPoint).
• Minimum 1 year in administrative support.
• Experience managing electronic TMFs and related systems.
• Thorough knowledge of ICH-GCP guidelines and local regulations.
• Willingness to travel up to 5% of hours.

Responsibilities

• Interact with Sponsors, sites, vendors, and Everest groups to enable high-quality trials.
• Prepare and review regulatory documents for authorities and ethics committees.
• Manage TMF/CTMS setup, maintenance, and archiving.
• Maintain essential document files for inspections and archives.
• Assist in site qualification, feasibility, and site selection processes.
• Support development of SOPs and study-specific documents.
• Coordinate investigator meetings and internal team events.
• Track study document shipment and monitoring metrics.
• Assist with data extraction from EDC/IWRS for PMs/CMs.
• Maintain study portals, newsletters, and progress reports.
• Process vendor/site invoices and payments.
• Support audits/inspections and prep activities.
• Contribute to RFP responses and broader operations tasks.
• Provide backup support across Clinical Operations as needed.

Skills

Excellent communication

MS Office

Admin support

Electronic TMF

ICH-GCP knowledge

Travel up to 5%

Education

Bachelor’s degree in Life Sciences or related field

Job description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Clinical Trial Assistant for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Job Accountabilities

• Interact with study Sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high-quality operationalization of clinical trials in compliance with ICH-GCP and relevant local regulations.
• Compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
• Assist with preparation and submission of regulatory documents to responsible authorities and Institutional Review Boards/Ethics Committees.
• Responsible for set-up, maintenance, and archival of studies in the Trial Master File (TMF) and Clinical Trial Management System (CTMS).
• Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in TMF. These files must be maintained in a fashion so that they are continuously available for inspection and completion for archive.
• Assist with site identification, feasibility questionnaire development and distribution, and site selection.
• Contribute to the development of Clinical Operations documents (i.e., Investigator Site File logs, newsletters, etc.) to facilitate the implementation and management of the clinical trial.
• Collaborate with meeting planners and vendors to arrange for Investigator meetings, off-site client meetings (i.e., kick-off meetings), or internal departmental meetings.
• Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.) and supplies, as needed.
• Track monitoring plan compliance metrics (i.e., monitoring frequency and monitoring visit report submission/finalization). Issue reminders to monitoring team.
• Distribute Suspected Unexpected Serious Adverse Reactions (SUSARs) to investigational sites and complete necessary tracking (acknowledgement of receipts, etc.).
• Assist with the download of reports from Electronic Data Capture (EDC) systems and Interactive Web Response Systems (IWRS) to prepare summary of data for Project Managers/Clinical Trial Managers.
• Maintain study portals, web sites, or newsletters.
• Compile reports progress/status of investigational sites.
• Assist with processing of vendor/site invoices and Investigator site payments.
• Participate in the development and maintenance of and adhere to departmental Standard Operations Procedures (SOPs) and guidelines.
• Collaborate with other team members to prepare, maintain, and complete training on study-specific and/or applicable Sponsor SOPs.
• Support sites and internal Clinical Operations efforts to prepare for inspections and/or audits conducted either by Everest, Sponsors, or regulatory authorities.
• Assist Clinical Operations team members with Requests for Proposals and other Clinical Operations tasks as needed.
• Provide support for Clinical Operations and other functional areas as needed.

Qualifications

• Bachelor’s degree in Life Sciences or related field of study.
• Excellent communication (both verbal and written) and computer skills.
• Expert use of the Microsoft Office suite is essential.
• Minimum of 1 year of experience in administrative support preferred.
• Experience in managing and maintaining electronic TMFs.
• Thorough knowledge of ICH-GCP guidelines and applicable regulations.
• Ability to travel a maximum of 5% of working hours is required.

Benefits & Compensation

We offer a robust benefits package to support your health, well‑being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $45,000 - 65,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.

We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.