ClinicalResearchAssociateII

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will: * Act as the main line of communication between the project team, sponsor, and the site * Build and maintain a good relationship with the site staff involved in the study conduct * Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits * Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level * Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations * Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level * Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites * Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level * Ensures quality (data integrity and compliance) at site level * Conduct site audit preparation visits and resolve site audit findings * Participate in study site audits and client onsite visits, as required * Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse * Conduct project-specific training of site investigators * Support preparation of Investigator newsletters * Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level * Support prepara