Responsibilities

The Senior Clinical Research Associate will provide guidance and oversight to the CRA team, ensuring adherence to project scope, SOPs, timelines, and budget requirements. They will conduct monitoring visits, review monitoring reports, and perform co-monitoring and evaluation visits as needed, while also coordinating with cross-functional departments to address site-related issues and facilitate study recruitment. The Sr CRA will assist in developing monitoring plans and training presentations, manage study budgets for stand-alone projects, and ensure the integrity of CRF data through meticulous source document review and verification. Furthermore, they will conduct site qualification, initiation, interim, and close-out visits, prepare monitoring visit reports, facilitate adverse event reporting, and maintain regular contact with study sites to ensure protocol and GCP compliance.