MedtronicClinical Project Coordinator
Sep. 2021 - Jun. 2023• Perform project administrative tasks including filing all required study and site related documentation, maintaining paper and electronic study files, and documenting adherence to trial master file (TMF) plans through periodic assessments
• Manage multiple sites and maintain detailed clinical study files and source documentation
• Proficient with conducting and completing qualification, initiation, activation, close-out activities and checklists
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
• Responsible for sending out essential correspondence, supplies and study binders to sites, configuration of the study’s Clinical Trial Management System (CTMS) while supporting the creation of required study templates and training materials
• Maintaining database cleaning such as opening and closing queries, familiar with EDC such as Medidata Rave and Oracle
• Proficient with data extractions utilizing sites such as CDA, Spotfire and Teams
• Track study training to ensure all the study and site team is fully trained on current plans
• Generate and execute site payments while adhering to study budgets
• Manage compliance with requirements of the protocol, informed consent process, data collection, and subject enrollment
• Develop clinical study documents including study protocol, informed consent forms, case report forms, and patient reported outcomes