Hybrid Respiratory Clinical Trials Lead

Hawthorne Health, Inc.; Gadsden (AL); On-site; USD 180,000 - 290,000; Full time

Job summary

Hawthorne Health, Inc. seeks a licensed MD to lead sponsor-initiated trials as Principal Investigator or Sub-Investigator. The role requires onsite leadership in Alabama with remote oversight and travel for key visits.

You will supervise the clinical research team, ensure GCP/ICH compliance, and manage study data, safety reporting, and responsible drug accountability. Ideal candidates will have experience with respiratory indications, strong FDA/ICH-GCP knowledge, and proven leadership.

Qualifications

• MD with at least three sponsor-initiated trials as PI or Sub-I.
• Current, unrestricted medical license.
• Experience with respiratory indications in trials or clinical settings.
• In-depth knowledge of ICH-GCP guidelines, FDA regulations, and ethical requirements.
• Proven leadership and team management skills.
• Excellent clinical judgment and decision-making abilities.
• Strong verbal and written communication in English.

Responsibilities

• Accurately document findings and contribute to ongoing trials, registries, or protocols.
• Oversee all aspects of trials at the research site, ensuring GCP/ICH compliance.
• Lead and supervise the clinical research team, including staff and sub-investigators.
• Delegate duties to qualified personnel and ensure training and oversight.
• Conduct remote review of patient assessments to ensure proper enrollment.
• Review laboratory results, ECGs, and other diagnostic tests.
• Make critical medical decisions regarding participant care and protocol deviations.
• Ensure complete, timely collection and documentation of study data.
• Communicate with sponsors, CROs, IRBs, and regulators.
• Manage investigational product accountability, storage, and administration.
• Participate in initiation visits, monitoring visits, audits, and inspections.
• Maintain ongoing medical education and stay current with advancements.

Skills

Clinical trial leadership

PI experience

Regulatory compliance

Team management

English communication

Education

MD/DO

Tools

ICH-GCP knowledge

FDA regulations

Job description

Hawthorne Health, Inc. seeks a licensed MD to lead sponsor-initiated trials as Principal Investigator or Sub-Investigator. The role requires onsite leadership in Alabama with remote oversight and travel for key visits.

You will supervise the clinical research team, ensure GCP/ICH compliance, and manage study data, safety reporting, and responsible drug accountability. Ideal candidates will have experience with respiratory indications, strong FDA/ICH-GCP knowledge, and proven leadership.