Principal Investigator - Clinical Research

Principal Investigator

About Us

Hawthorne Health is the leading community site network, with 50 sites across the U.S. and leveraging intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality, compliant research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients.

Traditional trial sites are often fragmented and inefficient. Hawthorne streamlines the process by making trials scalable, cost-effective, and patient-centric. By bringing research directly into communities, Hawthorne shortens timelines and helps bring better treatments to market, faster.

About the Role

Hawthorne Health is seeking a Clinical Principal Investigator on a 1099 contract opportunity to join our growing team and lead the investigation for our site.

Key Responsibilities:

• 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.
• Provide medical oversight and ensure the safety and well-being of study participants throughout the trial.
• Participate in the selection and evaluation of study protocols, ensuring feasibility and alignment with site capabilities.
• 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.

Position Requirements:

• Medical Doctor (M.D. or equivalent) degree from an accredited institution.
• Current, unrestricted medical license in the state of practice.
• Board certification in a relevant specialty preferred.
• Experience (e.g., 5 years) as a Principal Investigator or Sub-Investigator in clinical research trials across various therapeutic areas.
• 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 position requires remote oversight of clinical research site and may require occasional travel for meetings, conferences, or training.