Study Start up Submissions Coordinator

Job Summary We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in the Taiwan office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Responsibilities •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.