Clinical Research Assistant

Clinical Research Assistant – Toronto/Markham, Ontario, Canada

Location:

Toronto/Markham, Ontario, Canada. The role can be performed on‑site at our office or remotely from a home‑based office anywhere in Canada, in accordance with our Work from Home policy.

• Receive medical writing and safety monitoring projects and project information from the Direct Manager or Work Mentor. The project information may include the study protocol, CRFs, Investigator’s Brochure, etc.
• Support medical writing and safety monitoring teams by performing QC review of document deliverables, including CSR, protocols, IC forms, patient safety narratives, Safety Management Plans, scientific publications, and other documents intended for regulatory submissions.
• Perform consistency review of document formats, styles and overall layout according to a document style guide.
• Perform data verification (QC) on statistical programming outputs against data sources such as patient CRFs. Report discrepancies found during the QC procedure.
• Learn and perform document e‑publishing for clinical trial and regulatory documents, including CSRs and tables, listings and graphs (TLGs). Ensure final product meets publishing requirements and timelines.
• Assist with hard‑copy and electronic archiving of clinical trial documents, including filing within a Trial Master File, according to established practices.
• May act as a DMC/DSMB Secretary, producing meeting minutes and assisting the DMC/DSMB Administrator in planning, organizing and coordinating meetings and serving as the primary contact for day‑to‑day operations between members and the Sponsor.
• Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
• Keep current on Everest Guidance Documents training and with general requirements or guidelines issued by regulatory authorities and ICH.

• Bachelor’s degree in Clinical, Medical or Life Sciences. M.Sc. or higher preferred.
• Clinical trial experience in a pharmaceutical or CRO environment preferred.
• Experience with Phase I–IV clinical trials and knowledge of drug/medical device regulations and industry standards.
• Experience with an accepted clinical data capture and management system preferred.
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
• Good organizational skills, ability to adapt to changing priorities and manage multiple assignments with challenging or conflicting deadlines.
• Ability to maintain a high degree of confidentiality with clinical and client data.
• Detail‑oriented, customer‑ and quality‑focused.
• Excellent interpersonal and teamwork skills.
• Computing skills in Microsoft Office applications preferred.
• Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions.

We offer a robust benefits package to support 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 an opportunity to earn a performance‑based bonus.

Estimated Salary Range: $45,000 – $70,000.

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.