Job title:study startup submission coordinator(medpace)

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.
  Qualifications

• Bachelor's degree in the science field or equivalent combination of education and experience;

• At least 4 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 andregulatory 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.