Director of Site Operations-Clinical Research

About the role

As Director Site Operations, you will have line management responsibility for personnel at assigned sites, ensuring clinical conduct adheres to protocol requirements, local regulations, and investigator delegations. This role focuses on community-based research, developing innovative site solutions that operate within diverse communities. You will promote a healthy, collaborative, and open culture at your sites and across the company.

Responsibilities

• Community Site Leadership & Management
  • Champion and represent assigned research sites and communities internally and externally.
  • Invest time in hiring and building a healthy, compliant, high-performance culture within site teams.
  • Ensure sites are staffed with appropriately trained, experienced, and licensed personnel to conduct trials.
  • Collaborate with other Site Directors to secure backup and cross-licensed staffing for coverage during absences.
  • Maintain relationships with leaseholders to ensure effective collaboration and security of community site locations.
  • Guide site teams in setting clear personal and business goals, conducting reviews to foster collaboration, continuous improvement, and personal development.
  • Manage research site capacity in collaboration with leadership, sales, and fleet teams.
  • Prioritize patient experience and community engagement within research site teams.
  • Train and mentor research staff and teams.
  • Hold regular cross-site briefings to share experiences, lessons learned, and updates on targets.
  • Be physically present with teams regularly by:
    • Attending site tours, pre-study visits (PSVs), site initiation visits (SIVs), close-out visits (COVs), and monitoring visits.
    • Conducting site visits and reviews to support, coach, and evaluate needs.
    • Attending site audits and inspections.
  • Ensure effective collaboration between research teams, Principal Investigators, Patient Engagement, Regulatory, Project Management, and Fleet teams to deliver compliant and coordinated community research while mitigating risk.
  • Support Quality Assurance (QA) in communications and management of site clinical teams.
  • Perform site self-audits and monitor performance and productivity of assigned sites.
• Clinical Trial Management
  • Support sites in attracting, consenting, and retaining clinical trial participants.
  • Act as the primary point of contact for Project Managers regarding site-related matters.
  • Manage and develop Clinical Research Coordinators (CRCs) to ensure effective protocol training, system training, and study-specific support.
  • Collaborate with patient recruitment teams to meet project timelines and provide support as needed.
  • Monitor study randomization plans, patient retention, data completion, and overall compliance; take corrective action through cross-functional collaboration.
  • Address Corrective and Preventive Actions (CAPAs) openly and expediently.
  • Monitor study inventory usage and approve resupply requests.
  • Maintain open communication with the Project Management team to address supply chain and decision-making impacts on site delivery.
  • Serve as the customer point of escalation per the study communication plan.
  • Act as a liaison between project stakeholders and leadership, maintaining professional documentation for projects and deliverables.
  • Stay current with evolving clinical research technology and embrace innovation.
• Financial Management
  • Accountable for the profit and loss (P&L) of assigned research sites.
  • Forecast monthly enrollment goals in collaboration with Project Management.
  • Monitor performance daily and weekly to ensure monthly targets are achieved.
  • Forecast site resource needs and set staffing models to meet customer delivery goals.
  • Monitor site inventory usage and approve resupply requests.
  • Operate with a high degree of independence while adhering to competitive timelines.

Requirements

• Bachelor’s degree in health research, public health, science, or a related field.
• Five or more years of experience in the clinical research industry or equivalent.
• Three or more years of supervisory experience.

Skills

• Excellent communication skills, both spoken and written, with a willingness to seek clarification when needed.
• Ability to cascade initiatives to site teams and ensure their successful adaptation.
• Demonstrated attention to detail and adherence to instructions/procedures.
• Strong time management skills; efficient and resourceful in problem-solving.
• Ability to take ownership of work, demonstrate initiative, and follow through without supervision.
• Openness to receiving and benefiting from feedback; willingness to expand skill set and improve.
• Flexibility in adapting to new procedures and environments.
• Ability to work effectively in a team environment.
• Familiarity with research and data collection software.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• Company-paid short-term disability
• Flexible Spending Account (FSA)
• Health Savings Account (HSA)
• Paid Time Off
• Voluntary Benefits

Individual base pay depends on various factors, including primary work location, role complexity and responsibility, job duties/requirements, relevant experience, skills, and other market-based factors.