Director

• Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial.
• Reviewing and analyzing the eligibility of participants per inclusion/exclusion requirements of a clinical trial.
• Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
• Providing review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
• Ensuring activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations.
• Consulting with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments.
• Developing and/or reviewing operational, medical monitoring, and safety plans for studies.
• Leading and/or participating in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
• Generating safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
• Writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.

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