Senior CRA (Contractor) - French Speaking

Emerald Clinical Trials • North Frontenac, ON

3d • Remote

About The Position

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.

Requirements

• 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.
• Fluent French and English

Nice To Haves

• Previous nephrology/renal trial experience is highly desirable.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Part-time
• Career Level: Senior