Principal Investigator (MD/DO) - Dermatology Clinical Trials
Hawthorne Health, Inc.
Principal Investigator (MD/DO)
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 Dermatology trials within our growing, community-based site networkbuilt 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 Dermatology 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 35 hours per week).
$150 - $250 an hour. This is a 1099 independent contractor opportunity. Compensation may be flexible and adjusted based on experience and qualifications.
Hawthorne Health, Inc.Vacancy posted more than 2 months ago
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