Hawthorne Health

Investigator

• Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
• Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI.
• Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings.
• Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision.
• Assist the PI in making 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 the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities.
• Assist with investigational product accountability, storage, and administration according to protocol.
• Participate in site initiation visits, monitoring visits, audits, and inspections as required.
• Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas.

Sub Investigator, NP/PA-C

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/DO Consultant – Principal Investigator

Clinical Operations

• Provide operational oversight and support for multiple clinical research sites within the network.
• Monitor site performance metrics including enrollment, retention, protocol compliance, data quality, query resolution, and study timelines.
• Ensure consistent implementation of SOPs, operational workflows, and best practices across all assigned sites.
• Identify operational gaps and implement process improvement initiatives to enhance efficiency and site performance.
• Support study startup activities including feasibility, site activation, staffing readiness, staff training, and sponsor/CRO coordination.
• Partner with site leadership to optimize resource allocation, staffing coverage, and workflow management.
• Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
• Support audit readiness and assist with sponsor, CRO, and regulatory inspections/audits.
• Monitor protocol deviations, CAPAs, and quality-related issues and collaborate with site teams on corrective actions.
• Promote a culture of compliance, quality, and patient safety throughout the site network.
• Serve as a primary operational partner to PIs, Sub-Is, CRCs, and site staff.
• Provide mentorship, coaching, and operational guidance to clinical research personnel.
• Assist with onboarding, training, and ongoing development of site staff.
• Foster strong collaboration and communication across cross-functional teams and site locations.
• Track and report on key operational and financial metrics across assigned sites.
• Support achievement of enrollment targets, study milestones, and organizational growth initiatives.
• Collaborate with leadership on strategic initiatives, expansion opportunities, and operational scaling efforts.

Clinical Trial Site Operations Manager

Clinical Research

• Conduct and coordinate all aspects of clinical trial activities at the site.
• Perform phlebotomy on patients, following proper clinical and safety protocols.
• Recruit, screen, and enroll study participants according to inclusion/exclusion criteria.
• Schedule and conduct study visits, ensuring adherence to protocol requirements.
• Accurately collect, process, and ship biological samples per study-specific guidelines.
• Complete and maintain study documentation, including source documents, regulatory binders, and informed consent forms.
• Perform timely and accurate data entry into electronic data capture systems (EDC).
• Communicate effectively with sponsors, monitors, and other research team members.
• Ensure compliance with GCP, ICH, FDA, and IRB regulations.
• Assist in monitoring visits and audit preparation as needed.

Clinical Research Coordinator, CRC

Clinical Research Coordinator

Project Manager

• Build and configure CRIO studies based on approved protocols
• Design visit structures, assessments, forms, and workflows
• Ensure builds support regulatory expectations and clinical execution
• Perform build quality control to verify accuracy and integrity
• Update CRIO builds in response to amendments and feedback
• Maintain documentation of build validation and readiness
• Collaborate with Study Start Up / Regulatory teams
• Support internal team training on CRIO workflows

Sub Investigator, NP/PA-C

Sub Investigator, NP/PA-C

Sub Investigator, NP/PA-C

Sub Investigator, NP/PA-C

MD/DO Consultant – Principal Investigator

Clinical Trial Site Operations Manager

Clinical Research Coordinator, CRC

Clinical Research Coordinator

Clinical Project Coordinator – eSource Specialist