-Monitors clinical studies and sites for adherence to protocol, GCP, and company's SOPs; ensure timely enrollment against the operational plan.
-May supervise and/or mentor junior Clinical Operations personnel
-Oversees and is accountable for the adherence to timeline, study quality, budget for assigned studies and sites and participates in study timeline development
-Acts as the main line of communication between the sponsor and the investigator or other site personnel
-Verifies that all research staff have adequate qualifications and that the staff resource, facilities, investigational product storage, and accountability remain adequate throughout the conduct of the trail
-May perform root cause analysis to help improve the execution of clinical trials (i.e. helping with site activation, patient enrollment, or data cleaning issues)
-Ensures quality of data generated from clinical sites and assists in resolving data quality and protocol deviation issues
-May represent department at team meeting, may lead teams and participates in collaborative efforts (e.g. protocol development, CRA selection, etc.)
-Actively participates in CRO and other vendor selection process
-Prepares study-related documents including Informed Consent Documents (ICD), draft source documents, patient instruction guides and Case Report Forms (CRF)
-Tracks and presents study metrics including site activation, subject screening and enrollment, CRF completion, monitoring status
-Assists in the identification of clinical investigators
-Assists in the development of site budgets and facilitates routine site budget negotiations
-Tracks essential documents are received and maintained across assigned studies
-Manages the overall Investigational Product accountability and reconciliation process for assigned studies
