[Hiring] Study Start-Up Coordinator @Medpace, Inc.

Role Description

Our clinical operations activities are growing rapidly, and we are currently seeking 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 study start-up process at Medpace. As a Regulatory Submissions Coordinator with Medpace Canada, you will gain exposure to diverse, challenging studies across all phases and multiple therapeutic areas. 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.

• 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.

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.

Benefits

• Competitive compensation programs that recognize and reward performance;
• Comprehensive health, wellness, retirement, and PTO benefits;
• Office-based culture with occasional WFH that provides flexibility for eligible positions after training;
• Company-sponsored social events and intramural sports;
• A modern corporate campus designed to support collaboration and productivity;
• Multiple on-site dining options in the heart of Madison Square;
• Free on-site parking;
• Convenient access to on-site 24-7 fitness and wellness facilities.

Company Description

Medpace is a full-service clinical contract research organization (CRO) providing 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.