Clinical Research Coordinator III Team Lead

• 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

• 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

• Education: Bachelors 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

Required Experience:

IC