A-SPINE

Research Analyst

• Oversee the management and tracking of clinical trial data to ensure accuracy, integrity, and completeness.
• Conduct site qualification visits, site monitoring visits, and study close-out visits. Provide support to site staff during audits or inspections.
• Ensure clinical trials are conducted in compliance with protocols, Good Clinical Practice (GCP), ICH guidelines, SOPs, and regulatory standards (FDA/DEA).
• Review and manage electronic Case Report Forms (eCRFs), ensuring data is accurate and aligned with study protocols.
• Assist in the development and maintenance of Case Report Forms (CRFs) and other study-related documents.
• Provide training to site personnel on study procedures, protocols, and regulatory requirements.
• Regularly review data entered into the Electronic Data Capture (EDC) system to ensure compliance with study protocols.
• Identify, address, and escalate any study-related risks, issues, or opportunities for improvements.
• Follow up with clinical sites to ensure that data collection is progressing as planned and all required documentation is completed.
• Ensure timely and accurate management of regulatory documents and maintain compliance with regulatory requirements.
• Engage with Key Opinion Leaders (KOLs) in the medical and research communities to stay informed on scientific research and clinical data.
• Stay up-to-date with the latest developments in scientific research and clinical data relevant to Kuros Biosciences.
• Review and track clinical trial-related invoices, ensuring accuracy and compliance.
• Contribute to the creation and maintenance of project plans for clinical trials, ensuring alignment with company policies and timelines.
• Work independently to complete tasks while ensuring alignment with team objectives, timelines, and expectations.
• Expected to travel 3-5 days per month for site visits and clinical trial support.

Clinical Research Associate