Clinical Trial Coordinator

AbCellera•Montreal, QC

About The Position

We are seeking a highly organized, and detail-oriented Clinical Trial Coordinator (CTC) to join our Clinical Operations team. In this role, you will support the management of clinical trials from initiation to close-out, ensuring all trial-related activities are executed in compliance with regulatory requirements, Good Clinical Practice (GCP), and Company policies. Your role will be focused on supporting trial execution tasks, including maintaining trial documentation, coordinating meetings, handling logistics, and assisting with trial-related communications.

Requirements

At least 2 years of demonstrated work experience in a clinical research environment, in a similar role involving coordination of clinical trial activities
Hands-on knowledge of ICH-GCP and Good Documentation Practices
Outstanding cross-functional communicator and relationship builder
Proactive problem-solver, able to generate solutions independently
Ability to prioritize and thrive in a fast-paced environment
Operate with a high sense of accountability and accuracy

Responsibilities

Assisting with the preparation and submission of regulatory documents and clinical trial materials
Maintaining accurate and up-to-date trial documentation, including study files, regulatory binders, and essential records
Coordinating and scheduling meetings, preparation activities, and generating meeting minutes
Supporting the clinical team with tracking and reporting on project milestones, timelines, and deliverables
Assisting with the preparation and distribution of trial-related communications to clinical sites and vendors
Providing administrative support for the clinical team and other members as needed
Collaborating with colleagues to complete and review site activation documents and checklists for accuracy prior to drug shipment
Reviewing and tracking payment activities and tasks related to ECs/IRBs, investigational sites, and vendors
Assisting with the customization of CDAs, clinical site contracts, and budgets when applicable
Acting as the Primary Owner of the eTMF "Health Check", ensuring documents provided by CRAs are filed correctly and in real-time