Principal Investigator (MD/DO) - Respiratory Clinical Trials

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

Job summary

Hawthorne Health, Inc. in Concord, NC seeks an MD with proven leadership to oversee sponsor-initiated trials at our clinical research site. You will ensure GCP compliance, regulatory adherence, and high-quality data collection.

You will lead a multidisciplinary team, review safety and efficacy data, and coordinate with sponsors, CROs, IRBs. On-site presence is required with remote oversight as needed.

Qualifications

• 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 knowledge of ICH-GCP guidelines, FDA regulations, and related ethical/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

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, 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, CROs, 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

Skills

MD

Leadership

GCP Knowledge

Regulatory Knowledge

Respiratory Trials

English Communication

Medical License

Education

MD (Doctor of Medicine)

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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