Student Advisor I

Specific Job Duties

• Captures and manages clinical data for various phases of clinical studies.
• Ensures data is accurately documented and recorded as per requirements. Reads and interprets clinical data from medical records and assists in obtaining additional documents as needed.
• Enters required clinical data from medical records and patient research charts/reports into Clinical Research Forms (eCRFs/CRFs).
• Notifies Principal Investigator (PI) or Study Coordinator of any issues or violations.
• Acts as the primary point of contact with sponsors' Clinical Research Associates (CRAs) for externally sponsored trials. Manages data entry, planning and organizing monitoring visits, and responding to inquiries.
• Ensures compliance with federal regulations governing the protection of human subjects such as FDA, GCP/ICH guidelines, OHRP, HIPAA, and reporting of Serious Adverse Events (SAEs) and violations.
• Maintains data accuracy on Clinical Research Forms (eCRFs/CRFs) for in-house, NCI-sponsored, and Cooperative Group studies. Identifies and addresses basic data discrepancies and protocol violations.
• Follows up for study patient survival by reviewing medical records and contacting other institutions for data on patients hospitalized at other institutions.
• Assists with study specimen procurement and handling.
• Participates and attends internal and external new protocol start-up orientations and completes required protocol-specific training.
• Prepares and participates in audits of assigned studies such as NCI, FDA, and pharmaceutical audits.
• Participates in Quality Assurance Monitoring Committee (QAMC) in-house audits by reviewing assigned patient charts and reporting on findings related to protocol/patient compliance.
• Completes spreadsheets for industry studies in real-time to ensure sponsors are invoiced appropriately and promptly.
• Ensures confidentiality, accuracy, security, and appropriate access of all data and records.
• Performs other related duties as assigned or requested.

Qualifications

• Minimum Education: Bachelor's degree
• Minimum Experience: 1 year
• Minimum Field of Expertise: Experience in clinical trials data management
• Required Skills: Strong attention to detail, prior data entry experience, basic medical knowledge, strong verbal and written communication skills, ability to manage time efficiently.