Bilingual Study Start-up Coordinator Canada– Remote

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, remote-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. As a Regulatory Submissions Coordinator with Medpace Canada, you will have the opportunity to work with innovative therapeutic fields with exposure to diverse, challenging studies ranging from Phases I – III. On a day-to-day basis, you will have the opportunity to use your study start-up expertise to guide and administer internal processes, as well as advise clients on Health Canada requirements. With our continued growth in Canada, we are looking for proactive, positive, and self-motivated individuals with a shared commitment to quality to join our supportive and dynamic team.

• 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 clients on changing regulations and compliance requirements;
• Track and ensure timely filing of all documents related to Health Canada submissions.

• Proficiency inEnglish and French;
• 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 researchindustry experience with HealthCanada and Ethics submissions;
• Knowledge of ICH guidelines and applicable local regulations; and
• Excellent written and oral skills.