Clinical Research Associate

As a Clinical Research Associate (CRA), you will play a key role in conducting Phase I-IV clinical BA/BE studies. Your primary responsibilities will involve monitoring and managing activities at clinical sites to ensure that project timelines and deliverables are achieved. Building strong relationships with clinical sites and investigators will be essential, along with assessing protocol and regulatory compliance based on local and federal requirements, ICH GCP guidelines, and PSI SOPs. Your focus will be on safeguarding subjects" rights, safety, and well-being, as well as maintaining data quality. Your tasks will include preparing, conducting, and reporting on various activities such as site selection, initiation, routine monitoring, and close-out visits. Monitoring patient enrollment to meet recruitment targets and project timelines will be crucial at both site and country levels. You will be responsible for source data verification, resolving data queries, and conducting ongoing reviews to ensure data quality and compliance with Risk Based Monitoring practices. Timely reporting and follow-up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations will also be part of your duties. Acting as the main communication channel between the Sponsor and the site, you will serve as a point of contact for in-house support services and vendors. Proper handling, accountability, and reconciliation of Investigational Product(s) and study supplies will be under your supervision. Additionally, you will review essential documents at the site level and ensure the reconciliation of study OSF/TMF at the site and/or country level.,