About the Role
Hawthorne Health is seeking a Psychiatrist (MD/DO) to serve as a Principal Investigator in a part-time, 1099 capacity within our growing community-based clinical research network.
The Principal Investigator will lead sponsor-initiated psychiatric clinical trials, including studies focused on conditions such as anxiety and depression, while working alongside an experienced team of Sub-Investigators, Clinical Research Coordinators, and centralized clinical operations professionals.
Ideal candidates will have prior experience as a Principal Investigator or Sub-Investigator on sponsor-initiated clinical trials and an interest in advancing psychiatric research in a patient-friendly, community-based setting.
This is an opportunity to supplement your existing clinical practice while contributing to research designed to expand patient access to innovative treatment options.
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
- Experience leading at least three sponsor initiated trials as a PI or Sub-I, highly preferred.
- Current, unrestricted medical license.
- Board Certified or Board Eligible (BC/BE) in Psychiatry.
- 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.
Hawthorne Health is transforming the clinical trial landscape through an innovative site model that integrates research into community-based settings like local pharmacies. By meeting patients where they already receive care, we are improving access, strengthening trust, and driving more inclusive and efficient trials.
We welcome the opportunity to connect with individuals interested in being part of this evolving model.