Study Start up Submissions Coordinator

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

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 one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
* Excellent organization and communication skills;
* Knowledge of Microsoft(r) 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.
			

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