Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Verify the process of obtaining informed consent
• Assess factors that might affect subject/patient's safety and clinical data integrity
• Apply query resolution techniques
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required
• Understand project scope, budgets, and timelines
• Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• Adapt to changing priorities to achieve goals/targets
• Act as primary liaison with study site personnel
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards
• 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
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

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