Clinical Research Specialist

Clinical Research Specialist (24-month contract // REMOTE, team based in MN): HM's Top Needs: Site management experience, either at a clinical site or sponsor. Experience with clinical systems such as CTMS, EDC, and TMF. Knowledge of and experience with Good Clinical Practice (GCP) and clinical trial regulatory requirements. Description: The position will support the planning and execution of clinical research studies, including site management activities, study documentation, data review, and coordination with internal and external stakeholders. The individual will work under the direction of a Clinical Study Manager and help ensure studies are conducted in accordance with applicable SOPs, Good Clinical Practice (GCP), and regulatory requirements. Responsibilities may also include supporting study start-up and closeout activities and maintaining clinical systems and documentation. Years’ Experience Required: 1-2+ years of clinical trial and site management experience Duties: Oversees, designs, plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and non-registered 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. #J-18808-Ljbffr Redbock - an NES Fircroft company