System One Services Senior Clinical Research Associate in Des Plaines, Illinois
Senior Clinical Research AssociateDes Plaines, IL
Category:Scientific & Clinical
Job Title: Senior Clinical Research Associate
Contract Length: 8 mos
Number of Openings: 1
We are looking for a contractor to work in clinical affairs group on a critical IVDR project: converting EU (CE Mark) regulatory submission files to the new requirements. The qualified individual will be responsible for creating and updating clinical records and prepare information for regulatory submissions. The contractor will need to have experience with clinical studies (device/diagnostics is a plus), understand clinical documentation, be able to find relevant information, write or updates clinical reports/records, and work with statisticians to create data analyses. The candidate will also conduct literature searches and has to be familiar with clinical and scientific literature in order to be able to critically analyze and summarize clinical and scientific information in a formal record. The candidate must be detail-oriented and must have an ability to work and deliver in a high-pressure environment under stringent timelines.
M.S. degree or higher in science or clinical research, or equivalent experience. Experience with In Vitro Diagnostics (IVD). Research experience is a plus. Experience with molecular diagnostics, such as real-time PCR and in situ hybridization will be desirable.