Clinical Trial Assistant

<h1 style="font-weight:700;">Job Title: Clinical Trial Assistant</h1><br /><h2>Job Description</h2><p>We are seeking a dedicated Clinical Trial Assistant to join our dynamic team. The ideal candidate will provide essential support to the clinical operations team and contribute significantly to the management and success of clinical trial activities.<p><h2>Responsibilities</h2><ul><li>Provide general administrative support to the clinical operations team.</li><li>Support the clinical operations project team in managing clinical trial activities, including preparing and distributing meeting agendas, minutes, and presentations, maintaining action items and decisions logs, and tracking and escalating issues in a timely manner.</li><li>Ensure project team members' training records are set up, maintained, and up-to-date.</li><li>Manage the preparation and distribution of study supplies, such as investigator site files and study materials.</li><li>Distribute information to internal team members and external stakeholders, including contract research organizations, vendors, and sites.</li><li>Maintain various tracking and reporting tools and systems for the clinical operations team.</li><li>Maintain the clinical operations investigators database.</li><li>Participate in the site feasibility and site selection process.</li><li>Collect, track, and file essential site documents for the electronic trial master file under the guidance of the TMF Specialist.</li><li>Update site-specific ISF checklists throughout the study.</li><li>Communicate directly with CROs, clinical research associates, sites, and other internal team members to ensure timely collection and filing of documents required for the eTMF.</li><li>Contact clinical sites for specific requests such as enrollment updates and missing documentation.</li><li>Assist Associate Project Managers and Clinical Project Managers in reviewing clinical trial agreements and site budgets, creating tracking tools for site costs and payments, and verifying payment requests against completed visits and procedures in the eCRF.</li><li>Perform remote monitoring activities, including remote source data verification and data query resolution, remote ISF review, and reconciliation with TMF.</li><li>Support any clinical and regulatory operations activities deemed necessary for clinical program success.</li></ul><h2>Essential Skills</h2><ul><li>Clinical trial management</li><li>Clinical documentation and operation</li><li>Regulatory document handling</li><li>Clinical site support</li><li>Understanding of clinical research, GCP, and clinical data</li></ul><h2>Additional Skills & Qualifications</h2><ul><li>Minimum of a bachelor's degree in health sciences or a related field within life sciences, or equivalent experience.</li><li>Minimum of 2 years’ experience in a clinical trial assistant, project coordination, or in-house CRA role in a pharmaceutical or biotechnology company, or a CRO.</li><li>Previous on-site clinical monitoring experience is an asset.</li><li>Flexible, independent, and self-motivated.</li><li>Excellent oral and written communication skills.</li><li>Ability to prioritize, organize, plan, and execute multiple tasks and priorities simultaneously.</li><li>Commitment to high-quality work, research ethics, and willingness to learn.</li><li>Proficiency in software such as Word, Excel, PowerPoint, and other clinical systems like eTMF and Quality Management System (QMS).</li></ul><h2>Work Environment</h2><p>The role offers a flexible work environment with two days on-site, allowing for collaboration and dynamic interaction with team members.<p><h2>Pay and Benefits</h2><p>The pay range for this position is $65000.00 - $70000.00/yr.<p><h2>Workplace Type</h2><p>This is a hybrid position in Québec,QC.<p> </p> <p> </p> <h2>À propos d’Actalent: </h2><p> Actalent est un chef de file mondial des services d’ingénierie et de sciences et des solutions de talents. Nous aidons les entreprises visionnaires à faire progresser leurs initiatives en matière d’ingénierie et de science en leur donnant accès à des experts spécialisés qui favorisent la mise à l’échelle, l’innovation et la mise en marché rapide. Avec un réseau de près de 30 000 consultants et plus de 4 500 clients aux États-Unis, au Canada, en Asie et en Europe, Actalent est au service d’un grand nombre des sociétés Fortune 500. </p> <p>Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.</p> <p>Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à <a href="mailto:%20actalentaccommodation@actalentservices.com">actalentaccommodation@actalentservices.com</a> pour connaître d’autres options d’accommodement.</p> <p>Numéro du permis d'agence de placement de personnel : AP-2000486 (Canada – Québec)<br /> Numéro du permis d'agence de recrutement de travailleurs étrangers temporaires : AR-2000485 (Canada – Québec) </p> <h2>About Actalent</h2> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email <a href="mailto:%20actalentaccommodation@actalentservices.com">actalentaccommodation@actalentservices.com</a> for other accommodation options.</p> <p>Personnel Placement Agency Permit Number: AP-2000486 (Canada – Quebec)<br /> Temporary Foreign Worker Recruitment Agency Permit Number: AR-2000485 (Canada – Quebec)</p>