Safety Review Nurse

Job Title: Safety Review Nurse 100 % remote Duration: 12 Months Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings. Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills. Monitoring of safety-related queries to Investigators. Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision. Current with knowledge of ICH, FDA, and EMA regulatory guidance’s affecting safety surveillance.

Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests. In-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.