Job Title: Regional Clinical Research Associate
Job Number: 63451
Location: Remote, US
The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.
* Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out * Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion * Managing, preparing, sending, tracking, and returning investigational supplies at individual sites * Monitoring and documenting investigational product dispensing, inventory, and reconciliation * Monitoring and documenting laboratory sample storage and shipment * Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities * Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues * Reviewing data queries and listings, and working with the study centers to resolve data discrepancies * Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues * Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present * Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials. * Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs
* Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training * 2+ years of prior experience as a Clinical Research Associate, 4+ years for Senior CRA * Site monitoring experience is required
Application Deadline: 2023-10-20