Responsibilities:

• Conduct remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols
• Utilize data analytics and risk-based monitoring techniques to identify potential issues and trends
• Collaborate with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials
• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

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