Clinical Research Associate II

Qualifications Bachelor\’s degree in life science/related field, advanced degree preferred. Minimum of 4+ years in the clinical research industry. Proven track record in managing clinical trials and site monitoring. In-depth knowledge of clinical trial processes, GCP, and regulatory requirements. Strong organizational, leadership, and time-management skills. Excellent communication, problem-solving, and interpersonal abilities. Ability to handle complex issues and provide effective solutions. Capacity to work with and review large volumes of documentation and data. Ability to travel to and from clinical sites and manage site visit requirements. Combination of office work and travel to clinical sites, which may include healthcare environments and other clinical settings. Responsibilities Plan and conduct routine monitoring visits to evaluate site performance and compliance with study protocols, GCP, and regulatory standards. Oversee and support site staff in the execution of the study, including resolving complex issues and ensuring adherence to timelines. Perform site initiation, interim monitoring, and closeout visits. Review and verify source data against case report forms (CRFs) and other study documentation for accuracy and completeness. Identify, address, and resolve data discrepancies and issues. Ensure that data collection processes are efficient and compliant with protocol requirements. Ensure that clinical trials are conducted in accordance with regulatory requirements, including FDA guidelines, ICH GCP, and local regulations. Prepare and review essential documents and study records, ensuring compliance with regulatory standards. Assist in preparing for and managing audits and inspections. Provide training and support to junior CRAs and site staff on study protocols, procedures, and regulatory requirements. Mentor and guide less experienced team members, fostering professional development and ensuring high-quality performance. Act as a primary point of contact for study sites, addressing complex issues and facilitating communication between site staff and the study team. Collaborate with the study team to provide updates on site performance, study progress, and any issues or risks. Coordinate with cross-functional teams to ensure that study milestones and deliverables are met. Prepare detailed monitoring visit reports and ensure timely submission of site documentation. Assist in the preparation of study documentation, including protocols, amendments, and study reports. Maintain organized and accurate records of monitoring activities and site communications. #J-18808-Ljbffr