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System One Senior Clinical Research Associate - C in Maple Grove, Minnesota

Senior Clinical Research Associate - C

Contract Length: 6 mos

  • Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators.

  • Responsible for the initial budget and contract negotiations with study sites or CROs.

  • Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate.

  • 5+ Years Experience Level