Lead Clinical Research Coordinator - Onsite (Miami)

A prominent pediatric research organization is seeking an experienced Senior Clinical Trials Coordinator to take a lead role in the planning and execution of multiple ongoing and upcoming human subject research studies. This position will support a range of clinical investigations under the oversight of a centralized Clinical Trials Operations team and will play a key role in maintaining regulatory compliance, data quality, and participant safety throughout the research lifecycle.

This is a high-impact position offering the opportunity to work with cutting-edge clinical trials that support children and families, while also mentoring and guiding more junior research personnel.

Key Responsibilities :

• Project Leadership & Oversight
• Serve as the primary coordinator for several complex clinical trials, ensuring protocols are implemented accurately and efficiently.
• Act as a central point of contact between investigators, research staff, regulatory personnel, sponsors, and monitoring organizations.
• Monitor study progress and proactively identify and address operational bottlenecks or compliance risks.
• Participant Management
• Support participant recruitment efforts including eligibility screening, informed consent process, and enrollment procedures.
• Maintain ongoing contact with participants and families, ensuring follow-up activities align with protocol requirements.
• Data & Regulatory Compliance
• Maintain high-quality source documentation and manage accurate, timely data entry into clinical trial management systems (CTMS).
• Prepare and submit regulatory documents, amendments, and continuing review materials in collaboration with internal regulatory affairs teams.
• Ensure data collection adheres to GCP (Good Clinical Practice) and local / institutional policies.
• Mentorship & Team Support
• Provide daily guidance and training to less experienced coordinators and assistants.
• Assist with onboarding new staff and serve as a role model for protocol compliance, professionalism, and patient engagement.
• Reporting & Communication
• Compile and present updates on enrollment figures, site metrics, and project milestones to internal leadership.
• Collaborate with finance, regulatory, and data teams to support audit readiness and funding compliance.
• Attend investigator and operational team meetings to report on study status and address operational needs.

What Were Looking For :

Minimum Qualifications :

Preferred Skills & Competencies :

Why Join Us :

Work Environment :

Please note : This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team.