Senior Clinical Research Associate

Bilinguallink; Richmond Hill; On-site; CAD 90,000 - 120,000; Full time

Job summary

Bilinguallink is seeking a Senior CRA to support site selection and regulatory submissions for an international randomized clinical trial spanning Europe, Canada and the United States.

The role involves coordinating site onboarding, preparing ethics and regulatory packages, adapting documents to local requirements, and coordinating translations while providing country-specific regulatory guidance. Strong autonomy, late-stage study experience, and knowledge of regulatory frameworks are essential.

Qualifications

• Senior CRA with strong autonomy.
• Experience in site selection and submissions.
• Knowledge of local regulatory requirements.
• Late-stage study experience (phase II, III).
• Solid understanding of country-specific regulatory frameworks.

Responsibilities

• Site selection (including on-site visits if required).
• Support to site onboarding and informed consent preparation.
• Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities).
• Adaptation of documents to local requirements and translation coordination.
• Country-specific regulatory guidance.

Skills

Autonomy

Site selection

Regulatory submissions

Regulatory knowledge

Late-stage experience

Job description

The client is preparing the launch of an international randomized clinical trial (RCT) across Europe Canada, and the United States to support marketing authorization. Due to the absence of a full CRO model, key activities will be managed internally. We are therefore seeking experienced Senior CRAs to support site selection and regulatory submissions.

Scope of the mission

• Site selection (including on-site visits if required)
• Support to site onboarding and informed consent preparation
• Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities)
• Adaptation of documents to local requirements and translation coordination
• Country-specific regulatory guidance

Profile requirements

• Senior CRA with strong autonomy
• Experience in site selection and submissions
• Knowledge of local regulatory requirements
• Late-stage study experience (phase II, III)
• Solid understanding of country-specific regulatory frameworks
• Local language may be required depending on country