No longer accepting applications (expired, filled, etc.)
Hawthorne Health, Inc.
Principal Investigator (MD) - Rheumatology
This role involves leading Rheumatology clinical trials within a community-based site network, focusing on conducting standardized disease activity and damage assessments, managing clinical trial operations, and ensuring compliance with regulatory standards. The Principal Investigator will oversee clinical research teams, make critical medical decisions, and maintain communication with sponsors and regulatory bodies.
Key Responsibilities
- • Conduct standardized disease activity and damage assessments using validated instruments, including: SLICC/ACR Damage Index, BILAG (British Isles Lupus Assessment Group Index), SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index), CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index), Physician Global Assessment of Disease Activity (PGA), and Joint count assessment
- • 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
Required
- • Must be an MD with experience leading at least three sponsor initiated trials as a PI or Sub-I
- • Current, unrestricted medical license
- • 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
Preferred
- • Board certification in Rheumatology preferred
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, Rheumatology, clinical trials. This role will lead Rheumatology trials within our growing, community-based site network—built to make research efficient, patient-friendly, and investigator-supported.
Responsibilities
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, Rheumatology, clinical trials. This role will lead Rheumatology trials within our growing, community-based site network—built to make research efficient, patient-friendly, and investigator-supported.
Responsibilities
- Conduct standardized disease activity and damage assessments using validated instruments, including: SLICC/ACR Damage Index, BILAG (British Isles Lupus Assessment Group Index), SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index), CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index), Physician Global Assessment of Disease Activity (PGA), and Joint count assessment
- 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
- Must be an MD with experience leading at least three sponsor initiated trials as a PI or Sub-I
- Current, unrestricted medical license
- Board certification in Rheumatology 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
- This role requires on-site presence in Horsham, PA at least once per week (or more, depending on study needs), with additional work performed remotely
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