Clinical Trial Assistant - Markham, Canada - Everest Clinical Research

Everest Clinical Research

Verified Company

Markham, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

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 a committed, skilled, and customer-focused individual to join our winning team as a
Clinical Trials Assistant for our Toronto/Markham, Ontario, Canada, on-site location.

The Clinical Trial Assistant provides support to Clinical Operations for departmental and project related requirements for the activities that support the execution of a clinical trial from start-up to close-out.

JOB ACCOUNTABILITIES:

Interact with study Sponsors, investigational sites, vendors, and Everest functional groups to enable timely and highquality 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 setup, 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, offsite client meetings (i.e., kickoff 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 studyspecific 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.