Clinical Research Specialist

Clinical Research Specialist (24 month contract // Available on-site in Minneapolis, MN or Lafayette, CO) HM's Top 3: Site Management experience (site and/or sponsor) Knowledge of/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP) Years’ Experience Required: Minimum 2 years with Bachelor’s degree and 1+ years experience with advanced degree Description: Individual will be responsible for site management duties. Individual will serve as main contact for sites assigned to their care and ensuring sites are prepared for study participants, answer site questions, and ensure site milestones are met. Duties: Oversees, designs, plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets. May be responsible for clinical supply operations, site, and vendor selection. Must Haves: Experience with CTMS and patient data and site management systems (i.e. Veeva Vault, RAD Rave, Oracle) Experience with Microsoft Office Applications #J-18808-Ljbffr