Clinical Trial Coordinator- Regulatory

Clinical Trial Coordinator - Regulatory
Hybrid-Canada
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.
Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global – extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.
We are seeking a Clinical Trial Coordinator – Regulatory to act as primary contact with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team.
Responsibilities

• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
• Update status reports, applicable logs and tracking systems as applicable for the projects with input provided by senior staff
• Attend and present (as applicable) at meetings (e.g. sponsor, kick-off, face-to-face, study team)
• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis
• Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• Update study documents when there are changes in study personnel/study amendments

This position is performed through a combination of remote work and in-person at the client's Head Office.
Requirements

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works efficiently and effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Minimum 1-2 years of clinical research or relevant healthcare experience
• Able to work independently and as a team
• Fluent in French and English (verbal and written) and excellent communication skills
• Demonstrates commitment to customer focus, both internally and externally.
• Effective time management, organizational and interpersonal skills
• B.A./B.S. (Life Science preferred) or equivalent healthcare experience
• Effective communication with external customers (e.g. sites and investigators)
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

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