Charlottesville, Virginia5 days ago
May mix and/or dispense investigational product and instruct subjects on usage and potential drug interactions; Participates at pre-study and site initiation visits, investigator meetings, and other customer facing meetings, as needed; Assist site management with support in change management and process improvement; Assist and participate with new staff training and mentoring; Assist and guide employees on study specific tasks; Utilize and ensure the appropriate equipment is on-site for Universal Precautions for themselves and others in and around areas that may contain potential biohazards. Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines; Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study; Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents; Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.