Clinical Research Coordinator III - Team Lead

InsightChicago, IL
5dOnsite

About The Position

The Clinical Research Coordinator III – Team Lead is a senior-level hybrid role responsible for leading the coordination of complex clinical trials while supervising and mentoring the on-site research team. This position functions as a “player/coach,” combining direct study coordination with oversight of Clinical Research Coordinators and Clinical Research Assistants. The CRC III – Team Lead ensures operational excellence, regulatory compliance, and a culture of accountability and continuous improvement. This role also collaborates closely with the Patient Recruitment department to support enrollment success through candidate prescreening, outreach, and community engagement. In addition, the CRC III – Team Lead supports regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources.

Requirements

  • Bachelor’s degree in life sciences, nursing, or a related field preferred
  • Minimum 4 to 6 years of clinical research coordination experience, including leadership or mentorship responsibilities
  • Clinical research certification (e.g., ACRP, SOCRA) preferred
  • Proficiency in CTMS, E-Source, E-Reg, EDC platforms, and regulatory systems; strong computer literacy (Microsoft Office Suite, electronic communication tools)
  • Advanced understanding of clinical trial operations, GCP, FDA regulations, and IRB processes
  • Excellent written and verbal communication skills; ability to interact effectively with investigators, sponsors, staff, and participants
  • Demonstrated ability to supervise, mentor, and develop staff while fostering accountability and collaboration
  • High attention to detail, time management, and multitasking capabilities; ability to prioritize competing demands
  • Willingness to adjust schedule to accommodate study visits, meetings, and events that may occur earlier, later, or on weekends
  • Ability to travel to training meetings, conferences, satellite sites and other Insight Health System locations as required
  • Commitment to quality, compliance, participant safety, and continuous improvement

Responsibilities

  • Serve as lead coordinator on high-priority or complex trials, managing all phases from startup to closeout
  • Provide backup coverage and operational support for other coordinators during absences or escalations
  • Ensure protocol adherence, timely data entry, and accurate documentation across assigned studies
  • Supervise and mentor Clinical Research Coordinators I and II and Clinical Research Assistants
  • Lead onboarding, training, and ongoing development for study staff
  • Conduct regular team huddles, protocol reviews, and best practice sessions
  • Support regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources
  • Ensure accurate completion, review, and submission of IRB documents, amendments, and safety reports
  • Maintain essential regulatory files and sponsor communications
  • Participate in internal audits, monitoring visits, and CAPA implementation
  • Partner with the Patient Recruitment department to develop and execute enrollment strategies
  • Conduct candidate prescreening and outreach activities to support recruitment goals
  • Participate in community engagement efforts to raise awareness and build trust with potential participants
  • Serve as liaison between the research team, investigators, sponsors, and institutional departments
  • Assist in resource planning, visit scheduling, and workload balancing
  • Contribute to SOP development, workflow optimization, and quality improvement initiatives
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