Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits
• Ensure regulatory, ICH-GCP, and protocol compliance
• Provide guidance to site staff as necessary
• Verify informed consent process and document confidentiality
• Assess site processes and conduct source document reviews
• Apply query resolution techniques and provide guidance to site staff
• Utilize available hardware and software to support clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• Perform investigational product inventory, reconciliation, and reviews storage and security
• Routinely review Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, and communication logs
• 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 and communication
• Act as primary liaison with project site personnel
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards
• May provide training or mentorship to more junior level CRAs

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 adapt to 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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