[Hiring] Clinical Trial Assistant I @Everest Clinical Research

Role Description

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.

• 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

• Robust benefits package to support your health, well-being, and growth.
• Medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.