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The Role
Provide PI oversight for clinical trials at the Fremont site: ensure GCP/ICH compliance, supervise site staff, review assessments and diagnostics, manage investigational product, communicate with sponsors/CROs/IRBs, participate in visits/audits, and ensure patient safety and accurate study documentation.
Summary Generated by Built In
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 on a 1099 contract opportunity to join our growing team and lead the investigation for our new site in Fremont, CA.
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 as a Principal Investigator on at least 3 sponsor initiated clinical trials.
- Medical Doctor (M.D. or equivalent) degree from an accredited institution.
- Current, unrestricted medical license.
- Board certification in a relevant specialty preferred.
- 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 & Time Commitment
Flexible & Predictable Commitment
Designed with busy physicians in mind, this role offers a flexible time commitment that complements existing professional responsibilities. Most Principal Investigators average approximately 3–5 hours per week of remote medical oversight, along with periodic on-site engagement, typically averaging around two site visits per month. Dedicated operational and scheduling support helps ensure expectations remain predictable, manageable, and aligned with your availability.
PI must be within 1.5 hour commute to 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 mode
Skills Required
- Experience as a Principal Investigator on at least 3 sponsor initiated clinical trials.
- Medical Doctor (M.D. or equivalent) degree from an accredited institution.
- Current, unrestricted medical license.
- Board certification in a relevant specialty.
- Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements.
- Proven leadership and team management skills.
- Excellent clinical judgment and decision-making abilities.
- Strong verbal and written communication skills in English.
- 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.
- Must be within a 1.5 hour commute to the Fremont site.
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The Company
What We Do
Hawthorne Health is a clinical trial platform and community site network that integrates technology and medical professionals to make clinical trials more accessible, inclusive, and patient-centric. They operate across the U.S., supporting various therapeutic areas by embedding research in local communities and offering decentralized trial services to reduce barriers to participation, improve retention, and drive faster, more cost-effective research outcomes for study sponsors.
