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:
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significa
* Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
* Communication with the medical site staff
* Ensure good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
* Regulatory document review
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
* Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance
Qualifications:
* Experience as a Clinical Research Associate;
* Approximately 60-80% non-local, national travel is required;
* Must have a minimum of a bachelor's degree in a health or science related field;
* Proficient knowledge of Microsoft(r) Office;
* Fluency in French & English;
* Outstanding communication skills; and
* Must be detail-oriented and efficient in time management.
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