Clinical Research Associate II (Eastern Canada)

11 Premier Research International LLC; Quebec; Hybrid; CAD 65,000 - 85,000; Full time

Job summary

Premier Research is seeking a Clinical Research Associate II to join our Eastern Canada Clinical Monitoring, Site Management and SSU team. You will monitor trials across Phase I-IV and device studies with emphasis on data integrity and patient safety.

You will act as the main liaison with investigative sites, manage query resolution, participate in TMF activities, and ensure study timelines and budgets are maintained.

Qualifications

• Undergraduate degree required and 2+ years of clinical research monitoring experience.
• Must be able to travel 70-85% and visit sites frequently.

Responsibilities

• Perform monitoring activities (on site and remote) for Phase I–IV clinical trials and device studies.
• Ensure validity, accuracy, and completeness of data with emphasis on data integrity and patient safety.
• Serve as primary contact for investigative sites, manage queries, support Trial Master File activities, and participate in investigators’ meetings.
• Identify and escalate risks and retraining opportunities for investigative sites.
• Schedule and plan day-to-day activities, especially study monitoring visits and timely, high-quality trip reports.

Education

Undergraduate degree or international equivalent

Job description

Job Overview

Premier Research is looking for a Clinical Research Associate II (Eastern Canada) 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 elevate 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 along with minimum of 2+ years previous clinical research monitoring experience required.
• 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 Accountable, dependable and strong commitment Ability to meet the requirement of 8 DOS (Days on site)/monitoring visits/month; 70-85% travel, close to major airport French fluency preferred You must live in Ontario or Quebec

About Us

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.

Our Mission

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.

Company Overview

Premier Research 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.