Senior CRA; Contractor; French Speaking Clinical Operations

Location: Canada (Quebec preferred; remote with travel as required)
Duration: 12 Months
Commitment: Approximately 0.5 FTE
Language Requirement: Fluent French and English

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.

• 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 elevate study risks, issues, and quality concerns in a timely manner.

• Build and maintain strong relationships with investigators, site staff, and cross-functional project teams.

• 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…