Respiratory Clinical Trials Lead Investigator (PI)

Hawthorne Health; Gadsden (AL); On-site; USD 207,000 - 344,000; Full time

Job summary

Lever, Inc. is seeking an MD with proven leadership to manage on-site clinical trials, ensuring adherence to protocol, GCP, and regulatory requirements.

You will supervise sub-investigators and study staff, oversee patient assessments, data integrity, and safety monitoring, and communicate with sponsors and IRBs. Key responsibilities include site initiation, monitoring visits, audits, and staying current with clinical research developments in respiratory indications.

Qualifications

• MD with current, unrestricted license and leadership of at least three sponsor-initiated trials as PI or Sub-I.
• Deep knowledge of FDA regulations, ICH-GCP guidelines, and ethics in clinical research.
• Experience leading respiratory-indication trials and clinical teams.
• Strong leadership, organizational, and communication skills.

Responsibilities

• Accurately document findings and contribute to trials, registries, or research protocols.
• Oversee all site trial activities ensuring protocol and GCP adherence.
• Lead and supervise the clinical research team.
• Delegate duties to qualified personnel with proper training.
• Conduct remote review of patient assessments to ensure enrollment.
• Review lab results, ECGs, and other diagnostics.
• Make medical decisions on participant care and protocol deviations.
• Ensure complete and timely collection of study data.
• Communicate with sponsors, CROs, IRBs, and regulators.
• Manage investigational product accountability with IP team.
• Participate in site initiation, monitoring visits, audits, inspections.
• Maintain ongoing medical education and stay current in the field.

Skills

Leadership

Clinical oversight

Regulatory knowledge

Medical judgment

Education

MD degree

Medical license

Job description

Lever, Inc. is seeking an MD with proven leadership to manage on-site clinical trials, ensuring adherence to protocol, GCP, and regulatory requirements.

You will supervise sub-investigators and study staff, oversee patient assessments, data integrity, and safety monitoring, and communicate with sponsors and IRBs. Key responsibilities include site initiation, monitoring visits, audits, and staying current with clinical research developments in respiratory indications.