Senior/Principal Clinical Research Associate

				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:

* Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s);
* Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Medpace/Sponsor Standard Operating Procedures (SOPs);
* Serve as the primary resource to the clinical investigator and site staff;
* Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams; and
* Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak (r) Monitoring Portal.

Qualifications:

* Bachelor's degree in a health or science related field and with at least 5+ years of experience in clinical monitoring;
* Comprehensive knowledge of practices and procedures relating to all clinical monitoring visit types, including practical application of this knowledge;
* Demonstrated ability to act as a Lead CRA (as applicable);
Act as a resource for new CRAs and ability to facilitate training and serve as a mentor for new CRAs; and
* Implements new ideas/solutions, without prompting, within their authority.
			

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