Everest Clinical Research ("Everest") is a full‑service contract research organization providing a broad range of expertise‑based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. Everest has been an independent CRO since 2004 and is headquartered in Markham, Ontario, Canada with additional sites in Bridgewater, Current Jersey, Shanghai, and Taipei.

We serve recognized companies and work with advanced drugs, biologics, and medical devices. Everest is known for high‑quality deliverables, superior customer service, and flexibility in meeting client needs.

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 local regulations.

Compile documentation for qualification of clinical sites and support its review to ensure compliance with ICH‑GCP and local regulations.

Assist with preparation and submission of regulatory documents to responsible authorities and Institutional Review Boards/Ethics Committees.

Maintain the Trial Master File (TMF) and Clinical Trial Management System (CTMS) including set‑up, maintenance, and archival of studies.

Maintain and archive files of essential documents from investigative sites for TMF inclusion, ensuring they remain continuously available for inspection and archive.

Assist with site identification, feasibility questionnaire development, distribution, and site selection.

Contribute to the creation of Clinical Operations documents (e.g.,



Investigator Site File logs, newsletters) to facilitate trial implementation and management.

Collaborate with meeting planners and vendors to arrange investigator meetings, off‑site client meetings, or internal departmental meetings.

Ship and track trial documents (site binders, manuals, guides) and supplies as needed.

Track monitoring plan compliance metrics, issue reminders to the monitoring team.

Distribute Suspected Unexpected Serious Adverse Reactions (SUSARs) to investigational sites and complete tracking.

Assist with downloading reports from EDC and IWRS systems to prepare data summaries for Project Managers/Clinical Trial Managers.

Maintain study portals, websites, or newsletters.

Compile progress/status reports of investigational sites.

Process vendor/site invoices and investigator site payments.

Participate in the development and maintenance of departmental SOPs and guidelines.

Collaborate with team members to prepare, maintain, and deliver training on study‑specific and Sponsor SOPs.

Support sites and internal Clinical Operations efforts for inspections and audits conducted 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 required.

Qualifications

Bachelor’s degree in Life Sciences or a related field.

Excellent verbal and written communication skills.

Expertise in Microsoft Office suite.

Minimum one year of administrative support experience preferred.

Experience managing and maintaining electronic TMFs.

Thorough knowledge of ICH‑GCP guidelines and applicable regulations.

Ability to travel up to 5% of working hours.

Benefits & Compensation
We offer a robust benefits package 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 - $65,000.

To learn more about Everest Clinical Research and other opportunities, visit our website at www.everestclinical.com .

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.

#J-18808-Ljbffr

📌 Clinical Trial Assistant I (Ontario)
🏢 Everest Clinical Research
📍 Ontario