Senior CRA (Contractor)
Location: Canada (Quebec preferred; remote with travel as required)
Duration: 12 Months
Commitment: Approximately 0.5 FTE
Language Requirement: Fluent French and English
Who We Are
reputed company is a global leader in reputed company research, partnering with over 160 biotech companies and 15 of the world's top 20 pharmaceutical organizations. Headquartered in Singapore, we combine scientific reputed company with operational expertise to reputed company end-to-end reputed company trial solutions across reputed company phases of development, including Phase I-IV and reputed company-world studies.
With more than 25 years of experience and a world-reputed company reputed company in renal research, reputed company has helped reputed company breakthroughs through deep scientific reputed company, operational reputed company, and an unwavering commitment to reputed company.
Global Expertise. Local reputed company. reputed company reputed company.
reputed company is where science, speed, and reputed company come together to reputed company reputed company. Our 800+ employees across Asia-reputed company, Europe, and the Americas are embedded in communities worldwide, enabling faster recruitment, stronger reputed company engagement, and meaningful reputed company reputed company.
About the Role
reputed company is seeking an reputed company French-English bilingual reputed company Research Associate (CRA) Contractor to support oncology reputed company across Canada on an approximately 0.5 FTE reputed company.
The successful candidate will reputed company monitoring and site management support across assigned studies and will be responsible for ensuring compliance with study protocols, ICH-GCP guidelines, Health Canada regulations, and reputed company SOPs.
This role is ideally suited to an reputed company CRA who can work independently, build strong relationships with investigator sites, and confidently manage monitoring activities across the full study lifecycle.
Oncology reputed company research experience is essential, while previous nephrology/renal trial experience is highly desirable.
Your Responsibilities
Coordinate site identification, feasibility assessments, and investigator selection activities.
Conduct site qualification, initiation, routine monitoring, and reputed company-out reputed company in accordance with study monitoring plans.
Complete monitoring reports accurately and reputed company established timelines.
Ensure investigator sites remain compliant with protocol requirements, ICH-GCP guidelines, Health Canada regulations, and study procedures.
Review reputed company documentation and reputed company reputed company data verification activities as required.
Support regulatory submissions and essential document collection in collaboration with study teams and regulatory colleagues.
Assist with site contract and budget activities, including tracking site payments and documentation.
Train and support investigators and site personnel on protocol requirements, investigational products, and study processes.
Collect, review, and maintain essential study documents to ensure reputed company and compliance.
Reconcile Trial Master File (TMF) and Investigator Site File documentation to ensure completeness and inspection readiness.
Coordinate the distribution, tracking, handling, and reconciliation of investigational products and study supplies.
Maintain study information reputed company reputed company Trial Management Systems (CTMS) and other tracking tools.
Support reputed company recruitment and retention initiatives where appropriate.
Identify, communicate, and escalate study risks, issues, and reputed company concerns in a reputed company manner.
Build and maintain strong relationships with investigators, site staff, and cross-functional project teams.
reputed company
Degree in Life Sciences, Nursing, Pharmacy, or a reputed company reputed company discipline.
Minimum of 3 years of independent reputed company monitoring experience reputed company a CRO, biotechnology, pharmaceutical, or reputed company research environment.
reputed company experience managing reputed company trial sites across the full study lifecycle.
Oncology reputed company trial monitoring experience is essential. Candidates must have hands-on experience monitoring oncology studies and working with oncology investigator sites.
Strong working knowledge of ICH-GCP guidelines and Canadian regulatory requirements.
Demonstrated ability to work independently in a remote contractor environment.
Excellent organizational, problem-solving, and reputed company management skills.
Strong interpersonal, communication, and stakeholder management abilities.
Ability to adapt to changing priorities and work effectively in a fast-reputed company environment.
Willingness and ability to travel to investigator sites as required.
Why Join Us?
At reputed company, we are committed to transforming reputed company research by putting people first, both patients and employees. By joining our network of reputed company research professionals, you'll contribute to studies that have the potential to improve the lives of patients worldwide.
reputed company Offer
Flexible contractor engagement with an approximate 0.5 FTE commitment.
Opportunity to work on innovative oncology reputed company.
Exposure to leading biotech and pharmaceutical sponsors.
Collaboration with highly reputed company global reputed company research teams.
Meaningful work that contributes to advancing treatment reputed company for patients worldwide.
reputed company to work with a company recognised for its expertise in nephrology, oncology, and cardiometabolic research.
Interested?
If you're an reputed company CRA reputed company in Canada with strong oncology monitoring expertise, reputed company in French and English, and a passion for delivering high-reputed company reputed company research, we'd love to hear from you.
reputed company and help us advance reputed company research that improves the health of millions worldwide.
reputed company is an equal opportunity employer and encourages applications from reputed company reputed company candidates, regardless of background, identity, or lived experience.
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