AIXIAL GROUP

Research Analyst

• The Sr. CRA is responsible for site management and monitoring activities associated with clinical studies
• Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements and appropriate SOPs
• Confirm investigator adherence to ICH GCP, local regulatory requirements and to the protocol procedures
• Complete and submit timely site visit reports per the monitoring plan/SOPs
• Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting
• Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff
• Discuss, review, and document patient recruitment strategies with assigned sites
• Work with Project Leader (PL), and/or Clinical Team Lead (CTL)/Clinical Trial Manager (CTM) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan

Senior Clinical Research Associate, Contractor