The Senior Clinical Research Monitoring Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the lead of the Clinical Site Operations (CSO) Unit. The Sr. Clinical Research Monitoring Specialist is responsible for performing Good Clinical Practice (GCP) monitoring activities for University or faculty held Investigational New Drug (IND), Investigational Device Exemptions (IDE) and foreign Clinical Trial Applications (CTA) clinical research trials to verify human subjects are protected; the data are accurate, complete, and verifiable from source documents; and the conduct of the trial follows the approved protocol. The Senior Clinical Research Monitoring Specialist will: * Develop and maintain risk based monitoring plans to ensure quality and integrity of data, protection of human subjects, the trial is conducted in compliance with the study documents, GCP, and applicable regulations. * Participate in sponsor development meetings and Data Safety Monitoring Board Meetings to review, contribute and present on the progress of ongoing clinical trials. * Conduct or oversee vendors conducting initial, interim and close out monitoring visits in adherence to: the study-specific data safety monitoring plan (DSMP); protocol; applicable regulatory requirements; Sponsor Standard Operating Procedures (SOPs); and GCP/ICH guidelines. * Confirm appropriate documentation pertaining to investigational product storage, accountability, administration and chain of custody for each subject and to confirm only enrolled subjects receive investigational product. * Assess investigator oversight of the trial. * Perform the PI compliance training and site compliance management. Develop and implement corrective action plans, and communicate progress to Sponsor Regulatory team, and follow-up to ensure appropriate resolution of identified issues. * Ensure timely development and reporting of monitoring visit reports and follow up letters.
Internal Number: 46501
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