Job Summary

. Human Research Operations & Team Leadership

• Oversee study execution across the full research lifecycle, including:
  • protocol development and study start-up
  • active study operations
  • participant enrollment and study visits
  • study closeout and reporting
• Directly supervise a team of research assistants and junior staff, including hiring, onboarding, supervision, task allocation, performance management, and professional development.
• Ensure appropriate staffing, coverage, and workload allocation across studies.
• Provide ongoing coaching and guidance to research staff to support high-quality study execution and day-to-day operational reliability across studies.
• Serve as the primary operational point of contact for study teams, resolving day-to-day issues and ensuring smooth coordination across projects
• Support preparation and coordination of administrative and regulatory components of grant applications, working with investigators and pre-/post-award teams to ensure completeness, alignment with study operations, and timely submission

2. Research Execution Systems & Infrastructure

• Develop and maintain systems to support research operations, including:
  • project and portfolio tracking tools
  • dashboards and reporting frameworks
  • SOPs and standardized workflows
• Define and implement metrics to monitor study launch, progress, recruitment, and performance
• Maintain structured dashboards and trackers that identify project status, upcoming milestones, risks, and dependencies, and ensure this information is current and actionable
• Build scalable infrastructure that can be adopted across the division

3. Project & Portfolio Execution

• Translate research priorities into structured work plans with:
  • timelines
  • ownership
  • deliverables
• Track progress across projects and ensure adherence to milestones and deadlines
• Identify delays, bottlenecks, and risks early and implement corrective actions
• Work closely with investigators and study teams to ensure alignment and execution
• Actively enforce follow-through and accountability across research workstreams

4. Regulatory Compliance, Governance, & Quality Oversight

• Oversee regulatory and compliance processes, including:
  • IRB submissions, amendments, and renewals
  • protocol deviations and reportable events
  • maintenance of required regulatory documentation
  • adherence to Good Clinical Practice (GCP) standards
• Implement and maintain quality and compliance systems across studies, including regulatory oversight, data quality assurance, and protocol adherence across studies
• Ensure compliance with institutional, NIH, and sponsor requirements
• Coordinate with institutional compliance and research administration offices
• Ensure research staff maintain required certifications and are appropriately trained in and adhere to Good Clinical Practice (GCP) standards and institutional compliance requirements; monitor compliance and address gaps as needed

5. Administrative Systems & Operational Support

• Delegate execution of administrative tasks to research assistants or administrative staff and ensure appropriate oversight and completion
• Build and maintain systems for:
  • onboarding and training workflows
  • equipment and inventory tracking
  • operational logs and reporting
• Ensure reliability, completeness, and efficiency of operational processes

6. Cross-Functional Coordination (Research Interface)

• Ensure research operations are executed in accordance with divisional priorities, coordinating with division leadership and relevant functional leads as needed
• Coordinate dependencies between research operations and related functions (innovation teams, data/analysis, grants/finance, and executive operations), ensuring timelines and deliverables remain aligned
• Ensure research timelines are coordinated with grant submission cycles, data availability, and other operational dependencies
• Facilitate communication across teams to resolve operational issues and maintain momentum on shared workstreams

Qualifications

Required

• Degree in life sciences, public health, healthcare administration, or related field
• 5+ years of experience in human research operations, clinical trials, or research program management
• Demonstrated expertise in regulatory compliance and GCP standards
• Experience with study management systems (e.g., REDCap, OnCore)
• Experience building operational systems (dashboards, workflows, SOPs)
• Strong project management, organizational, and leadership skills

Preferred

• Project Management Professional (PMP) or equivalent certification.
• Certified Research Administrator (CRA), or equivalent certification
• Experience in academic medical centers or large research organizations
• Familiarity with NIH funding mechanisms and research administration processes

Core Competencies

• Execution discipline: drives projects forward reliably and on time
• Systems thinking: builds scalable operational infrastructure
• Accountability: enforces ownership, timelines, and deliverables
• Problem-solving: identifies and resolves bottlenecks proactively
• Leadership: develops and manages research staff effectively

Pay Range

Grade