Senior Clinical Research Associate (Canada)

14 Premier Research Group Canada Limited; Quebec; On-site; CAD 55,000 - 83,000; Part time

Job summary

Premier Research is seeking a Senior Clinical Research Associate (Canada) to join our FSP team in Ontario or Quebec on a part-time 6-month contract. You will conduct source verification, manage study documents, and contribute to site monitoring and budget discussions with clinical trial sites.

Fluency in English and French is required. The ideal candidate has a Bachelor's degree in a clinical, biological or health-related field and 5–7 years of on-site monitoring experience, with knowledge of

Qualifications

• Bachelor's degree in a clinical, biological, scientific or health-related field.
• 5–7 years of practical, on-site monitoring experience in clinical research.
• Experience with Phase 1 studies and regulatory compliance.

Responsibilities

• Perform source verification and ensure data accuracy against source documents.
• Review regulatory documents and device accountability records for quality.
• Investigate data discrepancies and escalate issues as needed.
• Maintain documentation and escalate non-compliance findings.
• Ensure reportable events are identified and reported per protocol.
• Manage study contracts and budget negotiations with sites.

Skills

Analytical skills

Organizational skills

Independent work

Multi-project management

Prioritization

Education

Bachelor's degree in clinical/biological/health field

Job description

Premier Research is looking for a Senior Clinical Research Associate (Canada) to join our Functional Services Provider (FSP) 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

• Conduct source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records.
• Issues, investigates, and resolves any data discrepancies identified during source verification activities.
• Maintains thorough documentation and proper escalation of issues related to visit reports.
• Ensures any identified non-compliance issues are addressed.
• Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
• Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
• Performs budget negotiations with clinical trial sites.

What We Are Searching For

• Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience.
• 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities.
• Alternately, must have proven experience in all primary job functions.
• Experience in Phase 1 studies.
• Fluent in English and French.
• Must be located in Ontario or Quebec, Canada.
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities.
• Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.

This is a part-time 6-month contract position with the potential to extend.

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 your 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.