Emerald Clinical Trials·North Frontenac, Ontario
The Senior CRA will conduct site monitoring and management activities to ensure compliance with study protocols, ICH-GCP guidelines, and Health Canada regulations. They will also manage essential study documentation, support regulatory submissions, and maintain strong relationships with investigator sites.
Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world's top 20 pharmaceutical organizations. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases of development, including Phase I-IV and real-world studies. With more than 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, operational excellence, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. Our 800+ employees across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide, enabling faster recruitment, stronger patient engagement, and meaningful clinical outcomes.
Emerald Clinical is seeking an experienced French-English bilingual Clinical Research Associate (CRA) Contractor to support oncology clinical trials across Canada on an approximately 0.5 FTE basis. The successful candidate will provide 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 Emerald Clinical SOPs. This role is ideally suited to an experienced CRA who can work independently, build strong relationships with investigator sites, and confidently manage monitoring activities across the full study lifecycle. Oncology clinical 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 close-out visits in accordance with study monitoring plans. Complete monitoring reports accurately and within established timelines. Ensure investigator sites remain compliant with protocol requirements, ICH-GCP guidelines, Health Canada regulations, and study procedures. Review source documentation and perform source 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 quality 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 within Clinical Trial Management Systems (CTMS) and other tracking tools. Support patient recruitment and retention initiatives where appropriate. Identify, communicate, and escalate study risks, issues, and quality concerns in a timely manner. Build and maintain strong relationships with investigators, site staff, and cross-functional project teams. About You Degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline. Minimum of 3 years of independent clinical monitoring experience within a CRO, biotechnology, pharmaceutical, or academic research environment. Proven experience managing clinical trial sites across the full study lifecycle. Oncology clinical 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 risk management skills. Strong interpersonal, communication, and stakeholder management abilities. Ability to adapt to changing priorities and work effectively in a fast-paced environment. Willingness and ability to travel to investigator sites as required. Why Join Us? At Emerald Clinical Trials, we are committed to transforming clinical research by putting people first, both patients and employees. By joining our network of clinical research professionals, you'll contribute to studies that have the potential to improve the lives of patients worldwide.
Flexible contractor engagement with an approximate 0.5 FTE commitment. Opportunity to work on innovative oncology clinical trials. Exposure to leading biotech and pharmaceutical sponsors. Collaboration with highly experienced global clinical research teams. Meaningful work that contributes to advancing treatment options for patients worldwide. The opportunity to work with a company recognised for its expertise in nephrology, oncology, and cardiometabolic research. Interested? If you're an experienced CRA based in Canada with strong oncology monitoring expertise, fluency in French and English, and a passion for delivering high-quality clinical research, we'd love to hear from you. Apply now and help us advance clinical research that improves the health of millions worldwide. Emerald Clinical is an equal opportunity employer and encourages applications from all qualified candidates, regardless of background, identity, or lived experience.
Candidates must hold a degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline and possess at least 3 years of independent clinical monitoring experience. Proficiency in both French and English, along with hands-on experience in oncology clinical trials, is essential.
Market context
In Ontario, Senior CRA contractor opportunities can attract competition from experienced monitors who combine independent clinical monitoring with oncology trial expertise and French-English fluency. A relevant life sciences or healthcare degree, remote readiness, and comfort with flexible contractor engagement can strengthen an application. The requirements and benefits here are AI-summarized from the original job description, helping you review fit and save research time before applying.
