Consultant Dermatologist

Overview

Protocol Review: The Investigator holds the ultimate responsibility for the conduct of the study as per the approved protocol. The investigator is responsible for reviewing the protocol, especially the technical aspects.

Responsibilities

• Technical Discussion: Participate in all study related technical discussions to ensure the protocol is scientifically correct and aligned with the research objectives.
• Study Initiation Meeting: Attend the study initiation meeting and present the entire study plan/dermatological or clinical assessment plan.
• Consent Process: Ensure subjects are enrolled in the study only after appropriate, voluntary, informed consent (per ICH GCP guidelines). Answer queries during the ICF process and obtain signatures from subjects.
• Dermatological Assessment: Perform clinical, visual, and photographic assessments per the approved protocol.
• Other Evaluations: Conduct medical history, physical examination, and general dermatological examination as required by the protocol.
• Lab Result Review: Review laboratory test results as required by the protocol.
• Safety Assessments: Studies conducted under dermatological control fall under the direct purview of a dermatologist to ensure subject safety. If a non clinical evaluator performs assessments, dermatological safety must be evaluated by dermatologists.
• Study Plan: Work with the Study Manager to prepare the study plan and schedule; participate in planning to ensure successful, seamless study management.
• Conduct trials: Conduct trials as per ICH GCP and protocol specified guidelines.
• Train study staff: Train study staff on study related procedures.

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