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Hawthorne Health

Posted 5 months ago

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Principal Investigator (MD/DO) - Respiratory Clinical Trials

Staten IslandHybridFull-time

AI Summary

A Principal Investigator (MD/DO) leads respiratory clinical trials within a community-based site network, overseeing study execution, team supervision, and regulatory compliance.

About this role

About Us
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. Hawthorne leverages convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients. Our community-based model shortens timelines and helps bring better treatments to market, faster.
About the Role
Hawthorne Health is seeking an experienced Principal investigator (MD/DO) for a part-time, 1099 role. Candidates should have prior experience as a PI or Sub-I on sponsor-initiated clinical trials. This role will lead Respiratory trials including Asthma within our growing, community-based site network—built to make research efficient, patient-friendly, and investigator-supported.

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 per month for key visits (or more, depending on study needs), with additional oversight responsibilities performed remotely (approximately 3–5 hours per week).

    • Skills

    AsthmaClinical Trial ManagementFDA RegulationsGood Clinical PracticeICH GuidelinesInvestigational Product ManagementMD DO LicensureRespiratory Trials

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