Clinical Research Associate II

Job description

About the job This position is responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).Serve as main CTI contact for assigned study sites. What You'll Do: - Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP - Assist with study start-up activities, including feasibility, pre-study activities and site selection - Collect, review and track essential/regulatory documents - Participate in and complete all general and study specific training as required - Participate in investigator, client and project team meetings - Create and implement subject enrol...