Clinical Research Associate II (Eastern Canada)

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 escalate 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

Perform clinical monitoring activities including site qualification, initiation, and close-out visits for Phase I-IV trials. Ensure data integrity and patient safety while serving as the primary point of contact for investigative sites.

Requires an undergraduate degree or international equivalent and at least 2 years of clinical research monitoring experience. Candidates must be able to travel 70-85% of the time and reside in Ontario or Quebec.

Identified from the job description. Confirm important requirements above.

• Clinical monitoring
• Site management
• Data integrity
• Patient safety
• ICH-GCP
• ISO 141155
• Trial master file
• Risk identification
• Oncology
• Pediatrics
• Rare disease
• Site qualification
• Site initiation
• Query resolution
• Influencing Skills
• Influencing Without Authority
• Research
• Biotechnology
• Management
• Customer Service
• Clinical Monitoring
• Clinical Research
• Clinical Trials
• Communication
• Data Integrity
• French Language
• Patient Safety
• Good Clinical Practices (GCP)
• Innovation
• Pharmaceuticals
• Trial Master File

• Healthcare
• Science & Research
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers

Minimum education

Bachelor’s degree

Minimum experience

2+ years

Posting language

English

Working hours

40 hours per week