Senior Clinical Research Associate (Canada)

Premier Research Group; Canada; Remote; CAD 65,000 - 90,000; Part time

Job summary

Premier Research is seeking a Senior Clinical Research Associate (Canada) for a remote part-time 6-month contract. The role supports biotech, medtech and specialty pharma clients across Canada, focusing on source verification, site management and regulatory documentation.

The candidate should have 5–7 years of on-site monitoring experience, Phase 1 work, and fluency in English and French, with Ontario or Quebec residency preferable.

Qualifications

• Bachelor's degree or international equivalent in a clinical/scientific/health-related field.
• 5–7 years of practical on-site monitoring and site management experience.
• Experience in Phase 1 studies.
• Fluent in English and French.

Responsibilities

• Conducts source verification by comparing data on CRFs against source documents.
• Issues, investigates and resolves data discrepancies from source verification.
• Maintains documentation and escalates issues related to visit reports.
• Ensures identified non-compliance issues are addressed and reportable events documented.
• Manages study contracts and collects investigator/site regulatory documents.
• Performs budget negotiations with clinical trial sites.

Skills

Onsite monitoring

Site management

Data verification

Budget negotiation

Regulatory documentation

Education

Bachelor's degree or international equivalent

Job description

## Senior Clinical Research Associate (Canada)Apply: Remote: Canada: Part time: Posted 18 Days Ago: R6995Premier 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:*** Conducts 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.**### Why Choose Premier?* 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.