Responsible for driving study execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site compliance with study protocols, informed consent procedures, and data integrity requirements. Ensure accurate documentation, timely reporting, and consistent implementation of best practices. Job duties:Identify, develop, and maintain investigators and sites capable of delivering start-up goals, enrollment targets, and required data quality. Facilitate and maintain open communication among investigational sites, study and data management teams, and the company. Ensure effective communication with key stakeholders. Ensure clinical studies are conducted in accordance with the protocol, GCP, company SOPs, and all applicable regulations (e.g., FDA). Understand, read, prepare, and deploy study documentation including, informed consents, study forms, and study training documents. Responsible for collecting and reviewing essential documents, facilitating necessary corrections, and filing in assigned system(s). Maintain device accountability records. Review data and source documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion. Conduct and perform site initiation visits, site training, interim monitoring visits, and close-out visits. Maintain accurate, detailed, and complete records of monitoring visits and reporting findings according to plans and processes. Collaborate with sites to ensure adherence to compliance requirements and escalates non-compliance when necessary. Draft study-specific Monitoring Plans in collaboration with a Project Manager and Clinical Quality Assurance. Assume Lead Clinical Research Associate responsibilities on assigned studies including reporting of monitoring KPIs. Serve as a mentor to more junior Field Monitors. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned.Salary Desired
$111,149-$138,936 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.