Hawthorne Health

Consultant

• 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
• Provide 3–5 hours per week of remote clinical oversight
• Attend the McAllen, TX site approximately 1–4 times per month for key visits

MD/DO Consultant – Principal Investigator, Clinical Trials

Project Manager

• Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance
• Assess protocol feasibility and support study planning, including resource allocation, budget considerations, and recruitment strategy development
• Drive study start-up timelines and coordinate with Regulatory, Contracts, and Budget teams for site activation
• Serve as the primary operational liaison for Sponsors and CROs, providing updates on study progress, risks, and mitigation strategies
• Develop and manage project plans, tracking milestones, timelines, enrollment targets, and study performance
• Monitor site metrics including enrollment, data entry, and query resolution, implementing study-performance optimization strategies
• Coordinate monitoring visits, audits, and investigator meetings
• Support regulatory and compliance activities, including essential document collection, IRB submissions, protocol amendments, and safety reporting
• Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions

Clinical Trials Project Manager

Clinical Research

• 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
• Ensure adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements
• Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff
• Delegate study-related duties to qualified personnel and ensure proper training and oversight
• Conduct remote review of patient assessments, physical exams, medical histories, and eligibility screenings
• Review and interpret laboratory results, ECGs, and other diagnostic tests
• Make medical decisions regarding participant care, adverse events, and protocol deviations
• Ensure accurate, complete, and timely collection and documentation of study data
• Communicate with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities
• Manage investigational product accountability, storage, and administration according to protocol with the on-site IP team
• Participate in site initiation visits, monitoring visits, audits, and inspections
• Maintain continuous medical education and stay current with clinical research and relevant therapeutic areas

MD/DO Consultant – Principal Investigator, Clinical Trials

Clinical Trials Project Manager

Psychiatrist – Principal Investigator, Clinical Research