Remote Study Start-Up & Regulatory Submissions Coordinator

medpace; United States; Remote; USD 46,000 - 75,000; Full time

Job summary

Medpace Canada is seeking a full-time Regulatory Submissions Coordinator to join our Clinical Operations team. This remote-based role supports Health Canada submissions and study start-up activities, working independently and with cross-functional teams to ensure timely, compliant filings across trials.

You will prepare, review, and file Health Canada applications, advise study teams on regulatory changes, and track essential start-up documents.

Qualifications

• Proficiency in English (required) and French (preferred).
• Ability to work in a remote setting.
• Bachelor’s degree in a science or health-related field.
• Experience working at a CRO is preferred.
• At least 3-5 years of clinical research industry experience with Health Canada and Ethics submissions.
• Knowledge of ICH guidelines and applicable local regulations.
• Excellent written and oral skills.

Responsibilities

• Act as the point of contact with sites during the study start up process.
• Prepare, review, and file clinical trial applications to Health Canada.
• Ensure submissions comply with applicable regulations and guidance documents.
• Advise study teams on changing regulations and compliance requirements.
• Track and ensure timely filing of all essential start-up documents including Health Canada submissions.

Skills

English proficiency

French proficiency (preferred)

Remote work ability

Excellent written and oral skills

Education

Bachelor’s degree in science/health

Job description

Medpace Canada is seeking a full-time Regulatory Submissions Coordinator to join our Clinical Operations team. This remote-based role supports Health Canada submissions and study start-up activities, working independently and with cross-functional teams to ensure timely, compliant filings across trials.

You will prepare, review, and file Health Canada applications, advise study teams on regulatory changes, and track essential start-up documents.