Regulatory Submissions Coordinator

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position plays a key role inthe clinical trial managementprocess at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

• Quality check on submission documents and site essential documents;
• Interaction with US Central IRBs, sites and international associates;
• Preparation and approval of informed consent forms; and
• Review pertinent regulations to develop proactive solutions to start-up issues and challenges.

• A Bachelor's degree in a relevant field and at least 0.5 year of pharmaceutical research experience, or Master's degree within Life Sciences;
• 1 - 3 years of work experience in a clinical trial environment;
• Knowledge of local regulations regarding clinical studies and the conduct of such studies;
• Strong oral and written communication skills;
• Excellent computer skills, including a working knowledge of Microsoft Office applications.
• Bilingual Japanese and English

Travel: Minimal