Principal Investigator (MD/DO) - Respiratory Clinical Trials

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

• Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable
• Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements
• Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff
• Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight
• Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment
• Review and interpret laboratory results, ECGs, and other diagnostic tests
• Make critical medical decisions regarding participant care, adverse events, and protocol deviations
• Ensure accurate, complete, and timely collection and documentation of all study data
• Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities
• Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team
• Participate in site initiation visits, monitoring visits, audits, and inspections
• Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas

Responsibilities

• Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable
• Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements
• Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff
• Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight
• Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment
• Review and interpret laboratory results, ECGs, and other diagnostic tests
• Make critical medical decisions regarding participant care, adverse events, and protocol deviations
• Ensure accurate, complete, and timely collection and documentation of all study data
• Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities
• Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team
• Participate in site initiation visits, monitoring visits, audits, and inspections
• Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas

Requirements

• Must be an MD with experience leading at least three sponsor initiated trials as a PI or Sub-I
• Current, unrestricted medical license
• Experience with respiratory indications in clinical trials and/or in a clinical setting
• Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research
• Proven leadership and team management skills
• Excellent clinical judgment and decision-making abilities
• Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely
• Exceptional organizational skills and meticulous attention to detail
• Ability to manage multiple complex studies simultaneously and prioritize tasks effectively
• Commitment to ethical conduct and patient safety

Location

• This role requires on-site presence approximately twice to four times per month for key visits (or more, depending on study needs), with additional oversight responsibilities performed remotely (approximately 3–5 hours per week)
• Preference is for Investigator to live within 1.5 hours driving distance of the site.

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