Clinical Research Associate II/Senior CRA - French Fluency

11 Premier Research International LLC; Quebec; Híbrido; CAD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Clinical Research Associate II/Senior CRA with French fluency to join our Clinical Monitoring, Site Management and SSU team in Quebec. You will monitor Phase I–IV trials and device studies, on-site and remotely, ensuring data integrity and patient safety while partnering with investigators and sponsors.

We value strong communication, independence, and a patient-focused approach.

Formación

• Bachelor's degree or international equivalent in a life sciences field.
• Minimum 4+ years of on-site clinical research monitoring experience.
• French fluency and based in Quebec are required.
• Willingness to travel 70-85% and conduct 8-10 on-site visits per month.

Responsabilidades

• Perform monitoring activities on site and remote for Phase I–IV trials and device studies.
• Ensure data accuracy, safety and compliance with trial protocol, ICH-GCP/ISO standards.
• Serve as main contact for investigative sites, manage queries and TMF activities.
• Identify risks and coordinate site retraining and timely study deliverables.

Conocimientos

French fluency

Clinical monitoring

Educación

Bachelor's degree or equivalent

Descripción del empleo

Premier Research is looking for a Clinical Research Associate II/Senior CRA - French Fluency to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What you'll be doing

• Perform monitoring activities (both on site and remote) including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Site Management Contacts, Close Out Visits for Phase I-IV clinical trials, as well as device trials with opportunities to work in the following Therapeutic areas: oncology, pediatrics, rare disease.
• Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
• Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators' Meetings, and complete other project tasks in accordance with study timelines and budget.
• Identify and escalating potential risks and possible retraining opportunities for investigative sites.
• Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high quality trip reports, and active management of all deliverables.

What we are searching for

• Undergraduate degree required or its international equivalent, along with minimum of 4+ years previous on-site clinical research monitoring experience required.
• Must have French fluency and be based in Quebec Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas Experience with monitoring oncology/neurology/rare disease/dermatology studies are preferred Accountable, dependable and strong commitment Ability to meet the requirement of 8-10 DOS (Days on site)/monitoring visits/month; 70-85% travel Valid driver's license, passport as required.

Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.