New Haven, United States
6 months ago
Responsible as Investigator (or Research Medical Provider) on the CRU accountable for all medical-legal, human safety & medical governance aspects of assigned clinical studies. Liaises with other sites regarding the design, conduct & progression of studies on the CRU. Supports Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient & compliant clinical operation of the CRU. Assists with the medical & clinical oversight of all aspects of function & work performed within the CRU. Works directly with clinical research personnel in reviewing lab data, performing physical assessments, medical histories, & evaluation of inclusion/exclusion criteria for study volunteers. Supports the implementation & application of PIMS in the CRU. Participates in the review & coding of adverse events & concomitant medications for accuracy & consistency. Participates in the review of source data and/or data listings of safety data, including adverse experiences, lab data, & vital signs data, to establish the presence or absence of abnormal trends, & if noted, follow-up as appropriate with the CRU clinical team, the CRU project team, the sponsoring site, & regulatory agencies. Participates in the review of individual adverse event reports for accuracy & clinical importance, & characterizes their relationship to the study drug, severity & seriousness.