Hawthorne Health

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

Clinical Project Coordinator – eSource Specialist

Operations

• Oversee day-to-day operations of all Hawthorne Health trial sites, including decentralized and hybrid models.
• Translate study scopes into operational strategies, including Manuals of Operations and project governance documents.
• Ensure efficient trial start-up, recruitment, conduct, monitoring, and close-out activities.
• Develop and standardize operational policies, SOPs, and performance metrics to optimize quality and consistency across sites.
• Ensure adherence to ICH/GCP guidelines, FDA regulations, company SOPs, and sponsor-specific requirements.
• Oversee regulatory submissions, IRB/IEC approvals, and site compliance documentation.
• Monitor site performance metrics, conduct audits, and implement CAPAs to uphold quality standards.
• Safeguard patient confidentiality and maintain compliance with HIPAA/PHI regulations.
• Lead, mentor, and develop site managers, coordinators, HEROs, and cross-functional operational staff.
• Build training frameworks for project-level and site-level execution to ensure consistency and readiness.
• Foster a culture of collaboration, accountability, and continuous improvement.

Director, Clinical Trial Site Operations

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

Call Center Representative

• Manage call center staff (inbound and outbound agents) and the pre-screening team: hiring, scheduling, coaching, QA, and performance management
• Execute study-specific pre-screening workflows built against protocol I/E criteria; ensure clean, accurate hand-offs to site CRCs
• Own core funnel KPIs — contact rate, lead-to-screen, screen-to-enroll, speed-to-lead, and cost-per-qualified-referral — and report weekly to the Head of Patient Recruitment
• Monitor call quality and script adherence; run ongoing QA, call calibration, and re-training
• Ensure all patient interactions are HIPAA-compliant and logged correctly in the CRM
• Partner with Project Management and Clinical Operations to align call volume with site capacity and enrollment velocity targets
• Troubleshoot operational issues in real time — staffing gaps, dialer/CRM issues, lead flow disruptions
• Surface pipeline risks early and recommend corrective action (script changes, staffing shifts, outreach intensification)

Hawthorne Health

Clinical Research Coordinator, CRC

Clinical Research Coordinator

Clinical Project Coordinator – eSource Specialist

Director, Clinical Trial Site Operations

Clinical Research Coordinator

Clinical Research Coordinator

Clinical Research Coordinator, CRC

Clinical Research Coordinator

MD/DO Consultant – Principal Investigator

MD/DO Consultant – Principal Investigator

Call Center Manager – Patient Recruitment, Pre-Screening

MD/DO Consultant – Principal Investigator

MD Consultant – Principal Investigator