Project Assistant- Clinical Safety

				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 a variety of support tasks to the Clinical Safety department, which may include bu not limited to processing safety reports, creating and distributing safety notification letters, tracking and filling of all corresponsence with Regulatory Authorities, Local Ethics Committees, Sites and/or GCP offices; 
* Prepare reports, presentations, agendas, correspondence, and meeting minutes as necessary; 
* Track, process, and organize various safety-related documents; 
* May perform basic research, answer questions from internal or external parties, or identify potential issues for further investigation in support of Clinical Safety department processes; 
* Develop understanding and perform tasks in accordance with assigned SOPs and policies; 
* Conduct quality control reviews of department documents, as necessary; 
* Maintain database/spreadsheets, as needed, to facilitate tracking/documentation of department activities; 
* May mentor and train less experienced project assistants; 
* Perform other duties as assigned by the Clinical Safety department.

Qualifications:

* A minimum of an Associate degree or equivalent;
* At least 1 year of clinical safety experience is necessary;
* Excellent organizational and prioritization skills are needed;
* Knowledge of Microsoft Office required; and
* Applicants should have great attention to detail and excellent oral and written communication skills.
			

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