Senior Clinical Research Associate

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

Job summary

Bilinguallink in Canada is seeking seasoned Senior CRAs to support multinational randomized clinical trials across Europe, Canada and the United States, focusing on site selection and regulatory submissions.

You will adapt documents to local requirements, coordinate translations, support onboarding, and provide country-specific regulatory guidance for late-stage studies (Phase II/III).

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 and coordinate on-site visits when required.
• Support site onboarding and informed consent preparation as needed.
• Prepare and compile packages for regulatory submissions (Ethics Committees / Authorities).
• Adapt documents to local requirements and coordinate translations.
• Provide country-specific regulatory guidance throughout the study lifecycle.

Skills

Autonomy

Site selection

Regulatory submissions

Late-stage study

Country-specific regulations

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