Clinical Research Coordinator III - Team Lead

Clinical Research Coordinator III – Team Lead

Department: Clinical Research Operations

Location: On-site (Insight Hospital & Medical Center Chicago)

Schedule: Full-time, Monday through Friday (8AM-5PM) –additional flexibility required to meet job requirements

Reports To: Director of Clinical Trials

Position Summary: 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.

Core Competencies

• Advanced knowledge of clinical trial operations, GCP, FDA regulations, and IRB processes
• Strong leadership and coaching skills with a collaborative, solutions-oriented mindset
• Excellent communication and interpersonal abilities across diverse stakeholders
• High attention to detail, time management, and multitasking capabilities
• Commitment to quality, compliance, and participant safety

Key Responsibilities

Study Leadership and Coordination

• 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

Team Supervision and Mentorship

• 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

Regulatory and Quality Support

• 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

Patient Recruitment and Engagement

• 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

Operational Collaboration

• 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

Qualifications and Requirements

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