• Conduct routine and end-of-study clinical site monitoring,ensuring compliance with the protocol, the NCI's Cancer Prevention ClinicalTrials Network (CP-CTNet) guidelines, the Code of FederalRegulations/International Conference of Harmonisation/Good Clinical Practices(CFR/ICH/GCP) guidelines, local regulations and applicable Standard OperatingProcedures (SOPs).
• Perform Quality Assurance (QA) duties on study materialssuch as source documents, patient-facing materials, checklists, and regulatorysubmissions.
• Identify and address any study-related issues, including butnot limited to inadequate or missing source documentation, adverse eventreporting, and protocol deviations or violations. 
• Maintain a thorough understanding of current monitoringpractices and applicable regulatory requirements and guidelines.
• Conduct routine internal monitoring of Lead AcademicOrganization (LAO) CP-CTNet trial activities.
• Review source documents and case report forms for clarity,consistency and accuracy.
• Prepare and/or modify monitoring documents. 
• Review and track regulatory and pharmacy documentation; tracksubject screening and enrollment.
• Maintain open, effective communication with study staff,Principal Investigator (PI), and leadership at UA as well as staff at Affiliate Organizations (AO),CP-CTNet, and sponsor-designated data coordinating center.
• Communicate with site staff to ensure adherence to protocoland regulatory guidelines and resolve problems in a timely manner.
• Actively participate in team meetings.
• Attend and participate in site initiation visits for CPreCP-CTNet trials.
• Provide support to AO staff preparing for external audits,as needed.
• Other duties as assigned.

Knowledge, Skills, and Abilities: 

• Demonstrated strong interpersonal and communication skills.
• Excellent technical writing skills.
• Adept at learning new software programs/databases.
• Excellent time management and organizational skills.
• High-level of attention to detail.
• Strong problem-solving skills.
• Ability to manage multiple priorities, projects, and tasks.
• A strong work ethic and a high degree of reliability and ability to meet deadlines.
• Ability to resolve issues independently.