Remote CRA for Cardiovascular Medical Device Trials

MiRus®; Montreal (administrative region); On-site; CAD 65,000 - 90,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Vision insurance

Disability insurance

Employee assistance program

Flexible spending account

Health insurance

Life insurance

Paid time off

Job summary

MiRus is seeking a Clinical Research Associate to support cardiovascular medical device studies, focusing on timelines, data integrity, and high-quality documentation.

The role requires a clinical nursing background with cardiac experience and familiarity with FDA/ICH/GCP guidelines, plus CRA certification is preferred. Travel may be required while contributing to cross-functional trial teams.

Qualifications

• Bachelor's or Master's degree in nursing with clinical experience in the cardiac field and clinical research experience.
• Proficient knowledge of FDA regulations and ICH/GCP guidelines and related standards.
• Experience in cardiovascular medical device trials and/or post-market registries is preferred.

Responsibilities

• Assist with management of cardiovascular clinical studies and ensure adherence to timelines.
• Prepare and edit study protocols, amendments, informed consents, charters, study reports and monitoring plans.
• Develop CRFs and instructional materials; train investigators and site personnel on trial conduct.
• Support safety monitoring including data review, and prepare documentation for committees and DSMB.
• Maintain study master files, trackers, dashboards, and regular trial status updates.

Skills

Clinical research experience

Data review

Regulatory knowledge (FDA/ICH/GCP)

Education

Bachelor's or Master's in nursing with cardiac clinical experience

CRA certification desired

Tools

CRF development

Study dashboards

Job description

MiRus is seeking a Clinical Research Associate to support cardiovascular medical device studies, focusing on timelines, data integrity, and high-quality documentation.

The role requires a clinical nursing background with cardiac experience and familiarity with FDA/ICH/GCP guidelines, plus CRA certification is preferred. Travel may be required while contributing to cross-functional trial teams.