Hawthorne Health

Clinical Coordinator

• Support more senior CSSs on complex or high-volume clinical research studies, assisting with ensuring visits are scheduled and re-scheduled within the visit window
• Manage low-volume or low-to-moderate complexity clinical research studies, ensuring visits are scheduled and re-scheduled within the visit window
• Monitor scheduled visits daily to ensure successful execution by checking equipment shipping, unconfirmed Hero visits, training gaps, and license confirmation
• Track rescheduled visit details to ensure rescheduling does not lead to non-compliance
• Review upcoming unscheduled visits for Hero availability gaps and escalate to the Stakeholder Engagement team
• Follow established SOPs and Work Instructions related to Visit Scheduling and Participant Outreach
• Interact with patients and Heroes during scheduling through visit completion
• Support coordination of logistics, supplies, and third-party vendors
• Meet visit scheduling goals and other KPIs
• Identify and communicate roadblocks and platform inefficiencies
• Collaborate with Project Managers, CLs, and Logistics teams to achieve in-window visit completion

Clinical Success Coordinator – Scheduling

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

MD/DO Consultant – Principal Investigator

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.

Hawthorne Health

Clinical Success Coordinator – Scheduling

MD/DO Consultant, Principal Investigator

MD/DO Consultant – Principal Investigator

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