Clinical Research Associate – Senior, Bilingual French/English

This is a fully remote position, open to applicants in Canada.

📋 Description

• Perform qualification visits, site initiation visits, monitoring visits, and termination visits at designated clinical sites.

• Create visit and contact reports.

• Establish and nurture site relationships as the primary point of contact.

• Address and resolve inquiries and issues from sites.

• Oversee the integrity of the study and site performance from initiation to close-out.

• Review trial performance and ensure the protection of human subject rights and well-being in line with the protocol.

• Collaborate with clinical sites to develop patient recruitment strategies that meet enrollment deadlines.

• Ensure adherence to SOPs, protocols and amendments, GCP, and relevant regulatory requirements.

• Assess the quality and integrity of reported data, site effectiveness, and drug accountability.

• Monitor the completeness and quality of regulatory documentation.

• Conduct verification of site documents.

⛳️ Requirements

• A minimum of 18 months of direct onsite monitoring experience as a Clinical Research Associate (CRA).

• Bachelor's degree or equivalent in biological sciences, pharmacy, or a related health discipline.

• Excellent interpersonal, written, and verbal communication skills within a matrixed team environment.

• Ability to work independently with a sense of urgency and minimal supervision.

• Client-focused attitude with adaptability regarding assignments and willingness to learn.

• Proficient in managing multiple tasks, assessing unpredictable situations, meeting project deadlines, and understanding study protocols.

• Commitment to an honest and ethical work ethic.

• Strong computer proficiency, including Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Excel, and Microsoft Word.

• Proficiency in written and spoken English and French.

🏝️ Benefits

• Bonus incentive program.

• Reduced travel requirements and a lighter protocol load compared to industry standards.

• Access to world-class technology.

• Training tailored to individual experience levels.

• Opportunities to work across multiple therapeutic areas.

• Potential for career advancement.

• Support for career growth through regular performance discussions and evaluations.