To support a global clinical program, the fully remote Clinical Research Associate will conduct site selection, initiation, monitoring, and close-out visits for various clinical trials while ensuring compliance with regulatory standards. Key responsibilities Conduct site selection, initiation, monitoring, and close-out visits for clinical trials, ensuring compliance with GCP, ICH, and protocol requirements Partner with investigative sites to enhance patient recruitment, enrollment, and retention strategies, supporting study timelines and performance goals Monitor site performance and protocol compliance, identifying quality concerns and implementing corrective actions to ensure data integrity and patient safety Required qualifications Bachelor's degree in Life Sciences, Healthcare, Nursing, Pharmacy, or a related scientific discipline preferred Minimum of 3 years of recent on-site clinical monitoring experience with direct involvement in Cardiovascular, CNS, Diabetes, and/or GLP-1 clinical trials Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes across multiple therapeutic areas Demonstrated ability to independently manage investigative sites and ensure high standards of data quality and patient safety Proficiency in Microsoft Office and clinical trial management systems, with excellent organizational and relationship-building skills
Clinical Research Associate • Durham, North Carolina, United States
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