Clinical Research Lead, RN

About Us

Hawthorne Health is the leading community site network, with 50+ sites across the U.S. and leveraging intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality, compliant research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients.

Traditional trial sites are often fragmented and inefficient. Hawthorne streamlines the process by making trials scalable, cost-effective, and patient-centric. By bringing research directly into communities, Hawthorne shortens timelines and helps bring better treatments to market, faster.

About this role:

The Clinical Lead will play a critical role in ensuring the quality, safety, and compliance of Hawthorne Health's clinical research operations. Reporting to the Chief Nursing Officer, this position will provide clinical oversight, support laboratory activities, guide protocol implementation, and deliver training and mentorship to clinical and operational teams. The Clinical Lead will serve as a subject matter expert and trusted resource for staff, ensuring adherence to regulatory requirements, study protocols, and best practices in patient care.

Leadership

• Partner with cross-functional teams (e.g. scheduling, logistics, supply chain, site operations) to ensure smooth execution of clinical trials.
• Support the Chief Nursing Officer in implementing strategic initiatives and scaling clinical research capabilities.
• Represent the clinical perspective in sponsor discussions, site feasibility, and protocol reviews.
• Serve as point of contact for clinicians and vendors.

Clinical Expertise, Oversight, and Guidance:

• Provide expert clinical support to operational teams, clinicians, and investigators.
• Review protocols and provide clinical insight (e.g. feasibility, training required, equipment and supplies needed, etc.).
• Act as a resource for clinical questions, troubleshooting, and escalations during study visits.
• Support clinical study start-up activities and develop the clinical training plan.
• Maintain strong understanding of diligence for clinical practice limitations by region.
• Identify credentialed clinicians (e.g. Principal Investigators, Sub- Investigators, RNs) to support studies during feasibility reviews and for assignment proposal.

Laboratory & Protocol Support

• Support laboratory related processes, including sample collection, handling, processing, and shipment.
• Ensure that clinicians follow appropriate biosafety, CLIA, and sponsor requirements.
• Assist in the review and development of laboratory manuals, workflows, and specimen handling instructions.
• Collaborate with the logistics team to ensure correct supplies, lab kits, and documentation are distributed and used appropriately.

Training & Development

• Design, deliver, and evaluate training programs on protocols, procedures, equipment, and clinical best practices.
• Mentor and guide staff on clinical decision-making, participant safety, and protocol adherence.
• Develop SOPs, work instructions, training materials, and other resources.
• Oversee the performance management process and provide remediation and re-training as needed.

Quality & Compliance

• Review, interpret, and ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Monitor clinical performance and adherence to study procedures to ensure data integrity and participant safety.
• Participate in corrective and preventive action plans and support the resolution of clinician related quality issues.
• Implement processes in compliance with regulations to promote workplace and lone worker safety.
• Support internal and external audits, inspections, and quality improvement initiatives.

Position Requirements

• The ideal candidate is organized, efficient, and comfortable working in a deadline-driven environment. The candidate will bring to Hawthorne Health the following skills and experience:

• A Bachelor of Science degree (or higher) in a scientific or healthcare related field, advanced degree (MSN, DNP, etc.) preferred

• Active and unencumbered Registered Nurse (RN) or Nurse Practitioner (NP) licensure required, compact licensure preferred
• Certification in clinical research (e.g., ACRP, SoCRA) is a plus
• Several years of experience in clinical research with extensive understanding of clinical trial regulations (e.g., FDA, ICH/GCP) and research methodologies, decentralized trial experience and/or clinical site experience required
• Strong project management and leadership skills to manage teams and deadlines
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems
• Exceptional communication, interpersonal, and negotiation skills for effective stakeholder collaboration

Location

• This position is remote, with potential to travel less than 5%. Candidate location preference is east coast as the role requires availability in east coast hours.

Featured benefits

Medical insurance, Vision insurance, 401(k), Dental insurance, Paid maternity leave, Paid paternity leave

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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