Bilingual Study Start-Up Coordinator Canada– Remote

Job Summary
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.
Responsibilities

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

Qualifications

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

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Organic Growth:Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
Perks ( vary by location and position ):

• On-site fitness center(s)
• On-site Market Place
• Company-sponsored social and wellness events
• Discounts for local businesses
• Free and covered parking
• Hybrid work-from-home options and flexible work schedule
• Official Sponsor of FC Cincinnati
• On campus restaurants and banks coming soon
• Campus walking paths

Awards:

• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets