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.

MD Consultant – Principal Investigator

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, coordinating with internal teams (Regulatory, Contracts, Budget) to ensure efficient site activation.
• Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
• Develop and manage project plans, tracking milestones, timelines, enrollment targets, and overall study performance.
• Monitor site metrics including enrollment, data entry, and query resolution, implementing strategies to optimize study performance.
• Coordinate monitoring visits, audits, and investigator meetings, ensuring site readiness and proper study execution.
• 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

Analyst

• Ensuring the data from visits is uploaded to the Hawthorne platform within a specific timeline.
• Reviewing project data within a specific timeline and delivering data in a timely manner to key stakeholders.
• Requesting and managing source/data corrections as needed.
• Uploading/entering data to third-party platforms (e.g., uploading echo images).
• Reviewing and resolving data queries.
• Participate in database lock activities.
• Perform a regular review (quality check) of data.
• Reviewing data for completeness and data quality/integrity (ALCOA+).
• Escalate or mitigate data issues according to Hawthorne standards.
• Ability to work with multiple different software programs.
• Assisting in the identification of potential adverse events.
• Notifying the appropriate stakeholders of potential adverse events in accordance with safety reporting timelines.
• Maintain project documents and project TMF

MD Consultant – Principal Investigator

Clinical Trials Project Manager

Cardiac Sonographer – Clinical Imaging Quality Analyst

MD Consultant – Principal Investigator