Clinical Research Associate Ii
CurrentPerformed on-site and/or remote monitoring visit activities in accordance with study protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and completed appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required.Verified the site adhered to appropriate reporting and documentation of adverse events, protocol deviations and subject enrollment as stipulated.Developed Clinical Monitoring Plans for assigned studies.Maintained working knowledge of GCP/ICH Guidelines as well as all applicable regulations.Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.Evaluate overall performance of assigned site and site staff to ensure site adherence to study timelines and budgets.Provided recommendations regarding site-specific actions and used judgment and experience to assess ability of site staff.Escalate quality issues to Clinical Project Manager (CPM) and/or line manager.Served as a resource to site coordinators, investigators, and other team members regarding investigational products and protocols.Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) and electronic CRF (eCRF) completion and submission, as well as data query generation and resolution.Act as the main liaison between the sponsor and study site by maintaining contact with the sites via telephone calls and emails between site visits and by responding to site concerns and questions.Helped the Clinical Project Manager with design of study materials, documents, and processes.Participated in Investigator's Meeting of assigned studies as assigned by Project Manager.
