In-house Clinical Research Associate

Sr. In-house Clinical Research Associate needed in North Chicago, Illinois Suburb.

Compensation is commensurate with experience.

The selected candidate will join 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 CRF's, 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 CRO's. 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.

Candidates who have experience in managing sites, CROs and project management are highly preferred. In addition, candidate should have experience in monitoring and managing Phase 3 studies as well.

Requirements:

Masters Degree Preferred. 10+ years experience is required.