Icon - Blue Bell, PA
posted 3 months ago
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment that drives innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. In this role, you will be responsible for organizing and delivering analyzable reports and metrics to the clinical study lead. You will also schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings. Your contributions will include collating data for assessments such as feasibility and site selection, as well as reviewing the site usability database. You will play a key role in the review of study documents, including informed consent forms and case report forms, and facilitate study document reviews according to company standard operating procedures. Additionally, you will compile study manuals, including study reference binders and manuals, and maintain versioning of study reference materials such as regulatory, pharmacy, and laboratory binders. Tracking site activation, enrollment, and monitoring visits to projected plans will be part of your responsibilities, and you will escalate any issues or delays with site activation or deviations from the monitoring plan. Your role will also involve monitoring and updating investigator/site status for the trial, supporting clinical trial registry postings, and performing scheduled reconciliations of the study Trial Master File (TMF) with guidance from the clinical study lead. You will ensure that scheduled reports are received, manage and maintain team SharePoint and/or shared drive sites, and communicate with sites as directed while maintaining site contact information. You may also manage or contribute to the oversight of Third Party Vendors (TPV) and track and monitor close-out activities, including study close-out documents and CRA close-out visits. Participation in Standard Operating Procedures (SOPs) revisions or departmental initiatives and proactively recommending process improvement initiatives for the department will also be part of your role.