Clinical Research Coordinator III - Team Lead

Job Title: 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