This temporary role supports the Genetic Counseling project team by working on operations related to reimbursement, collecting follow-up data, serving as a liaison between other departments, and assisting with product improvements. The role communicates with Prior authorization, Claims and Appeals, and lab teams to troubleshoot issues, verify samples, and streamline processes. Also, it assists with data collection for projects, tracks payment resolution outcomes, and reviews billing and coding changes.
Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites.
Performs data review of clinical trial data, including query management, and reconciliation review of external data against EDC data. May assist in creating study documents or running study reports and metrics. Files study documentation in electronic Trial Master File (eTMF) and department project files. Assists with quality review of activities performed by the CRO, as needed, and ensures compliance with own Learning Curricula, corporate and/or GXP requirements.