A Sub-Investigator (also known as Co-Investigator) is a medical professional who helps lead clinical trials but works under the main Principal Investigator. Think of them as the second-in-command in clinical research studies. They handle important tasks like examining patients, making sure safety rules are followed, and helping collect research data. This role is common in hospitals, research centers, and pharmaceutical companies that run clinical trials. It's similar to being an assistant coach on a sports team - they have significant responsibilities but report to the head coach (Principal Investigator).
Served as Sub-Investigator on Phase III diabetes drug trial with 200 patients
Sub-Investigator responsible for patient safety monitoring in 5 concurrent clinical trials
Led patient assessments as Sub-Investigator and Co-Investigator for oncology studies
Typical job title: "Sub-Investigators"
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Q: How would you handle a situation where you notice a potential safety concern in a clinical trial?
Expected Answer: They should explain the process of reporting safety concerns, including documenting the issue, immediately notifying the Principal Investigator, reporting to the Institutional Review Board if necessary, and following safety reporting protocols.
Q: Describe your experience managing multiple clinical trials simultaneously.
Expected Answer: Should demonstrate ability to prioritize tasks, maintain separate study protocols, manage different patient groups, and discuss systems they've used to stay organized and compliant across multiple studies.
Q: What is your process for ensuring accurate data collection in clinical trials?
Expected Answer: Should discuss following study protocols, proper documentation methods, double-checking data entries, and working with Clinical Research Coordinators to maintain data integrity.
Q: How do you ensure patient compliance with study protocols?
Expected Answer: Should explain patient education techniques, communication strategies, follow-up procedures, and methods for encouraging protocol adherence while maintaining ethical standards.
Q: What are the key responsibilities of a Sub-Investigator?
Expected Answer: Should mention patient assessment, protocol adherence, data collection, safety monitoring, and working under the Principal Investigator's supervision.
Q: How do you maintain patient confidentiality in clinical trials?
Expected Answer: Should discuss HIPAA compliance, proper handling of patient information, secure data storage, and maintaining patient privacy during study procedures.