Senior/Principal Study Start up Submissions Coordinator
Medpace
- Taipei City
- Permanent
- Full-time
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare, review, and submit to Regulatory Agencies;
- Communicate with global study teams and personnel on study progress;
- Ability to effectively identify risks to site activations and mitigate as necessary;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submission-related activities;
- Direct contact with investigative sites during the study start up and activation process;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
- Bachelor's degree in the science field or equivalent combination of education and experience;
- At least four years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- Excellent organization and communication skills;
- Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines;
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
- Good command in English.
- On-site fitness center(s)
- Campus walking paths
- Company-sponsored social and wellness events
- Official Sponsor of FC Cincinnati
- Hybrid work-from-home options and flexible work schedule
- On-site Market Place
- Free and covered parking
- Discounts for local businesses
- On campus restaurants and banks coming soon
- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
- Recognized by Forbes as one of America's Best Mid-size Companies in 2021
- 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
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati