Clinical Trial Specialist, French Speaking

This is a fully remote position, open to applicants in Canada.

📋 Description

• Assist with clinical trial operations as the in-house expert for site initiation and ongoing management.

• Ensure that clinical trials adhere to Federal Regulations, ICH guidelines, project plans, IRB/Ethics Committee standards, and relevant SOPs and protocols.

• Oversee the feasibility assessment processes in collaboration with the project team.

• Organize start-up activities for trials, including the collection of essential site documentation.

• Submit necessary materials to central IRBs/Ethics Committees.

• Provide support to site personnel regarding local IRB/Ethics Committee submissions and modifications to informed consent forms.

• Establish, maintain, review, conduct quality checks, and archive Trial Master Files.

• Upload and manage TMF files and directories within the file-sharing platform.

• Act as a secondary reviewer for TMF quality assurance and potentially lead the setup, maintenance, and oversight of TMF.

• Prepare for and engage in audit responses.

• Conduct quality checks on documents and emails prior to distribution.

• Maintain data and files/folders in the Clinical Trial Management System.

• Assist with the entry, tracking, and submission of investigator payment data.

• Collaborate with CRA/CTM/PM during site initiation and serve as a primary contact for sites as needed.

• Help present final feasibility outcomes to the project management team and/or sponsor.

• Support sites in preparing, planning, organizing, and gathering essential document packets.

• Submit finalized essential document packets to the sponsor or CTM/PM.

⛳️ Requirements

• College/University diploma/degree; OR a minimum of 2 years of related experience and/or training; OR a suitable combination of education and experience.

• Capability to perform general administrative tasks as required or necessary.

• Familiarity with medical terminology is preferred.

• Understanding of ICH/GCP, ethical, and regulatory standards is preferred.

• Proficiency in both French and English is essential.

• Knowledge of Federal Regulations, ICH guidelines, IRB/Ethics Committee standards, and relevant SOPs and protocols.

• Ability to assist with clinical trial feasibility, site initiation, essential document collection, IRB/Ethics Committee submissions, and alterations to informed consent forms.

🏝️ Benefits

• Engaging work that contributes to clinical trials aimed at improving lives.

• Flexible working options, including hybrid or remote arrangements based on location and position.

• Opportunities for learning and access to a worldwide network of scientific leaders.

• Employee wellness initiatives that promote work-life balance, health, and team cohesion.

• Participation in global engagement surveys.

• Recognition programs for outstanding contributions.

• Team-building activities.

• Exposure to a variety of international projects and clients.