Site Manager, Clinical Trial Operations

About Hawthorne Health

Hawthorne Health is a prominent network of community sites and home research visit services, operating over 20 locations nationwide with more than 2,000 healthcare professionals experienced in research throughout the U.S. The company utilizes convenient healthcare settings, patient data, and advanced technology to streamline patient access, improve retention, and reduce costs associated with studies. This model integrates high-quality research into local communities, making clinical trials more convenient and accessible while accelerating timelines to bring better treatments to market.

Role Overview

We are seeking a Clinical Trial Operations Site Manager to oversee and enhance multiple research sites located in Tennessee, Alabama, North Carolina, and South Carolina. This position involves significant travel within the assigned territory and is well suited for someone enthusiastic about fieldwork, building strong site partnerships, and supporting operational excellence in a fast-growing company. As one of the initial Site Managers, you will have the opportunity to directly influence the development of site operations, contributing to the creation and standardization of processes and best practices.

Key Duties

• Lead and provide on-site operational support for several clinical research sites across the designated region.
• Act as the primary operational contact for assigned sites, proactively resolving challenges to ensure successful study conduct.
• Manage vendor partnerships and agreements that facilitate efficient site functioning.
• Assist with study startup tasks including feasibility assessments, site activation, staffing, training, and coordination with sponsors and CROs.
• Track study performance indicators such as enrollment, retention, protocol adherence, data quality, query responses, and timelines.
• Recognize operational issues and implement scalable improvements to optimize efficiency and site results.
• Collaborate with leadership to create and unify operational procedures, workflow standards, and best practices across the expanding site network.

Compliance and Quality Assurance

• Maintain compliance with GCP, FDA regulations, ICH guidelines, HIPAA, sponsor protocols, and internal quality standards.
• Prepare sites for audits and facilitate inspections from sponsors, CROs, and regulators.
• Monitor and manage protocol deviations, CAPAs, and quality issues in partnership with site teams.
• Promote a culture prioritizing compliance, quality, and patient safety at all assigned locations.

Leadership and Relationship Building

• Develop trusted partnerships with Principal Investigators, Sub-Investigators, Coordinators, pharmacists, and other site personnel.
• Provide hands-on operational guidance and support to assigned sites on a daily basis.
• Support recruitment, training, and continued education of site staff to encourage consistency within the network.
• Address complex site and investigator relations with professionalism and a problem-solving approach.
• Encourage collaboration and communication across teams and sites.

Sponsor and Vendor Engagement

• Establish and maintain productive relationships with sponsors, CROs, vendors, and external collaborators.
• Represent the company effectively during sponsor meetings, operational reviews, and escalation events.
• Ensure prompt communication and resolution of issues that could impact study performance or sponsor satisfaction.

Business and Performance Management

• Monitor key performance indicators for operations and report trends and improvement opportunities to leadership.
• Help meet enrollment targets, study milestones, and operational goals.
• Work with leadership on launching new sites, expanding the network, and implementing strategic operational initiatives.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or relevant fields is preferred.
• Minimum 5 years in clinical research with recent direct experience at research sites (roles such as CRC, Lead CRC, Site Manager, or similar).
• Strong understanding of GCP, FDA regulations, ICH guidelines, and clinical trial operations.
• Experience collaborating with sponsors, CROs, Principal Investigators, and clinical site personnel.
• Proven ability to manage multiple priorities over multiple locations with attention to detail.
• Excellent skills in communication, organization, relationship management, and problem-solving.
• Familiarity with clinical research technology such as CTMS, EDC systems, and Microsoft Office.
• Willingness and ability to travel regularly (up to 30%) within Tennessee, Alabama, North Carolina, and South Carolina.

Preferred Experience

• Background supporting operations in multi-site clinical research networks or site management organizations (SMO).
• Experience developing or optimizing operational workflows in growing organizations.
• Proven success in building strong relationships with Principal Investigators and handling complex site environments.
• Experience facilitating audit readiness and regulatory inspections.
• Knowledge across therapeutic areas including cardiology, CNS, metabolic disorders, vaccines, dermatology, and respiratory studies.

Additional Details

• This position is remote but necessitates frequent travel to assigned research sites.
• Ideal candidates reside in Eastern or Central Time Zones.
• Regular travel up to 30% is required.