Principal Investigator - Respiratory

Overview

The Clinical Principal Investigator (PI) provides oversight and medical leadership for respiratory or pulmonary clinical research studies. This PRN role ensures all research activities are performed in compliance with regulatory, ethical, and scientific standards and that subject safety is prioritized at all times.

Responsibilities

• Serve as the responsible investigator for assigned respiratory trials.
• Review and approve study protocols, informed-consent forms, and case report data.
• Evaluate and monitor study participants with respiratory conditions.
• Supervise sub-investigators and clinical staff; ensure GCP compliance.
• Oversee study drug accountability and documentation.
• Liaise with sponsors, CROs, and IRBs; prepare for audits or inspections.
• Analyze study outcomes and contribute to safety and efficacy evaluations.

Qualifications

• MD (or equivalent) with an active, unrestricted medical license in the respective state.
• Board certification in Pulmonary Medicine, Internal Medicine, or related specialty preferred.
• 5 years of clinical research experience as a PI or Sub-Investigator.
• In-depth knowledge of respiratory therapeutics, FDA, and ICH-GCP standards.
• Strong leadership, organizational, and communication skills.