Senior Clinical Research Coordinator - Pediatric Trials Lead

Nicklaus Children's; Miami (FL); On-site; USD 70,000 - 100,000; Full time

Job summary

Nicklaus Children's is seeking a Sr Clinical Research Coordinator (Full Time, Days) to independently manage complex clinical trial activities. You will oversee day-to-day study operations, ensure protocol adherence, and maintain GCP/IRB compliance while supporting recruitment, data management, and regulatory documentation.

The role includes training junior staff and coordinating with investigators and sponsors.

Qualifications

• Bachelor's degree with 3.5+ years of research experience, OR Associate's degree with 6+ years, OR 7 years total research experience.
• Experience in pediatric clinical research in a hospital setting.
• Clinical research certification (CCRC, CCRP, CRA) and IATA certification.

Responsibilities

• Assist management with business development efforts.
• Attend investigator meetings, pre-study visits, and initiation meetings as appropriate.
• Collect and maintain accurate patient data for submission to Sponsor and coordinate specimen collection/shipments.
• Communicate study objectives to hospital units and establish rapport with the Principal Investigator.
• Coordinate communication between Investigator and Sponsor or Sponsor’s Representatives.
• Ensure compliance with Research Finance policies and procedures.
• Interact with patients and families to recruit study subjects and ensure protocol compliance.
• Maintain up-to-date electronic patient files and required documents in e-regulatory system.
• Provide training and mentoring to junior staff and volunteers.
• Enter data into CTMS and provide study status updates to staff for digitization/entry.

Skills

Pediatric clinical research

Communication skills

Organizational skills

Attention to detail

Clinical trial experience

Regulatory knowledge

Education

Bachelor's degree

Associate's degree

7 years research experience

Tools

CTMS

e-regulatory system

Job description

Nicklaus Children's is seeking a Sr Clinical Research Coordinator (Full Time, Days) to independently manage complex clinical trial activities. You will oversee day-to-day study operations, ensure protocol adherence, and maintain GCP/IRB compliance while supporting recruitment, data management, and regulatory documentation.

The role includes training junior staff and coordinating with investigators and sponsors.