Senior Clinical Research Associate

Bilinguallink; Saguenay; On-site; CAD 85,000 - 125,000; Full time

Job summary

Bilinguallink is seeking a Senior CRA to support an international randomized clinical trial across Europe, Canada and the United States. You will guide site selection and regulatory submissions, coordinating translation and document adaptation as needed.

We expect solid experience in late-stage studies (Phase II/III), strong autonomy, and knowledge of local regulatory requirements. Local language skills may be required depending on country and site location.

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.
• Local language may be required depending on country.

Responsibilities

• Lead site selection activities and site visits as needed.
• Support site onboarding and informed consent preparation.
• Prepare and package regulatory submissions (Ethics Committees / Authorities).
• Coordinate adaptation of documents to local requirements and translation.
• Provide country-specific regulatory guidance.

Skills

Site selection

Regulatory submissions

Autonomy

Language considerations

Late-stage trials

Education

Senior CRA certification

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