CRA II/III: Flexible Hours & Site Partnerships in Trials

Novotech; Montreal (administrative region); On-site; CAD 70,000 - 140,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Job summary

Novotech in Montreal, QC seeks a Clinical Research Associate to safeguard participant rights and ensure data integrity across sites. You will be the primary liaison between Investigators, site staff, Novotech, and Sponsors, coordinating ICH GCP compliance and regulatory SOPs.

Responsibilities include building strong site relationships, supporting ethics submissions, monitoring visits (onsite or remote), site TMF upkeep, and ensuring timely data queries resolution.

Qualifications

• Fluent in French is mandatory.
• Graduate in a clinical or life sciences-related field.
• Experience ranges per CRA level (CRA II–Senior CRA) as described in the posting.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists and site staff to ensure smooth trial management.
• Coordinate with IHCRA, RSA and RSU to support regulatory submissions and approvals.
• Ensure participant rights and safety, verify eligibility and admissibility for trials, and report adverse events to the sponsor.
• Monitor investigational sites per ICH GCP and CMP across all trial phases, onsite or remote as required.
• Maintain TMF documentation and ensure site readiness for audits and inspections.

Skills

Fluent in French

Education

Graduate in clinical or life sciences

Job description

Novotech in Montreal, QC seeks a Clinical Research Associate to safeguard participant rights and ensure data integrity across sites. You will be the primary liaison between Investigators, site staff, Novotech, and Sponsors, coordinating ICH GCP compliance and regulatory SOPs.

Responsibilities include building strong site relationships, supporting ethics submissions, monitoring visits (onsite or remote), site TMF upkeep, and ensuring timely data queries resolution.