Study Start up Submissions Coordinator

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.

Bachelor’s degree in the science field or equivalent combination of education and experience;
At least one year 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.