Senior Clinical Research Associate

The Senior Clinical Research Associate will play a crucial role in the set-up and execution of groundbreaking studies. This position will work together with the Sr. Director, Clinical Operations on the study start-up and infrastructure items from the initial phases of study set-up to hands-on clinical monitoring and site management. Conduct qualification, initiation, monitoring, and closeout visits at research sites in accordance with approved protocol(s), GCP, SOPs, and applicable regulatory requirements. Complete monitoring visit reports and visit letters that includes complete summaries and accounts of onsite activities. Verify medical record and source documentation against case report form (CRF) data, including informing the site staff of any entry errors, ensuring good documentation practices (GDP) are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory regulations. Ensure IRB/EC submissions and applicable regulatory documentation with proactive follow-through to ensure site readiness and study progress. Follow-up with clinical sites on all open action items, IRB/EC submissions, and subject status. Serve as the primary operational liaison between Synchron and investigative sites, focused on study conduct, protocol execution, data integrity, and patient safety. Verify adequate investigator qualifications, training resources, sufficient study staff, and appropriate investigator oversight. Contribute to the development of case report forms , informed consent documents, and other essential trial documentation. Support tracking and reporting study progress including site performance and data collection. Assist with ensuring proper documentation, audit readiness, and inspection compliance Assist with TMF (Trial Master File) setup and oversight. Support vendor oversight and management to ensure adherence to contracted deliverables. Ensure adherence to GCP, ICH guidelines and applicable regulatory requirements.