Country Start Up Specialist

at  Medpace Inc

Job Summary :
Join Medpace in CABA! As a Regulatory Submissions Coordinator you will have the opportunity to work within the Regulatory Submissions team, supporting our many projects and gaining vital experience in the study start up and site activation process of clincial trials. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands on experience to enable you to develop a career in clinical research.

Responsibilities :

• Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
• Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
• Conduct quality control of documents;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
• Perform other tasks as needed.

Qualifications :

• Bachelor’s degree is required (preferably in a Life Sciences field) and at least 1 - 4 years of regulatory submissions experience;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills; and
• Fluency in spoken and written English.

• Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
• Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
• Conduct quality control of documents;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
• Perform other tasks as needed