Clinical Research Coordinator III - Team Lead

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

• 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

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