Senior Clinical Research Coordinator - Pediatric Trials

Nicklaus Children's Health System; Miami (FL); On-site; USD 70,000 - 110,000; Full time

Job summary

Nicklaus Children's Health System seeks a Senior Clinical Research Coordinator (SCRC) to manage day-to-day activities of complex pediatric trials under the CTO. The SCRC ensures protocol adherence, regulatory compliance, and GCP/IRB requirements, while coordinating data collection, enrollment, and study documentation.

The role includes mentoring junior staff, collaborating with investigators, sponsors, and IRBs, and supporting business development and study start-up activities.

Qualifications

• Bachelor's degree with 3.5 years of research experience (OR) Associate's degree with 6 years of research experience (OR) 7 years of research experience.
• Experience in pediatric clinical research in a hospital setting.
• Clinical research certification (CCRC, CCRP, CRA) and IATA certification.
• 5+ years research or Clinical Research Experience preferred.
• Experience with interventional clinical trials.
• Experience working on clinical trials, interventional studies all phases.
• Bilingual in English/Spanish.
• Excellent communication skills with children and adults.
• Excellent organizational, time management and attention to detail.
• Knowledge of protocols and its process.

Responsibilities

• Assists management with business development efforts.
• Attends investigator meetings and initiation meetings.
• Collects and maintains accurate patient data for submissions to Sponsor.
• Communicates study objectives to hospital units and PI; provides assistance.
• Facilitates study monitor visits and communication between PI and Sponsor.
• Ensures compliance with NCRI, AAHRPP, HIPAA, and FDA guidelines.
• Interacts with patients and families to recruit and enroll subjects.
• Ensures speedy and adequate patient enrollment as approved by Research Management.
• Performs data entry into CTMS and keeps regulatory documents up to date.
• Trains and mentors junior research staff.

Skills

Pediatric clinical research

Regulatory compliance

IRB/GCP

Data management

Communication

Bilingual English/Spanish

Education

Bachelor's degree in research

Associate's degree

Tools

CTMS

Office software

Job description

Nicklaus Children's Health System seeks a Senior Clinical Research Coordinator (SCRC) to manage day-to-day activities of complex pediatric trials under the CTO. The SCRC ensures protocol adherence, regulatory compliance, and GCP/IRB requirements, while coordinating data collection, enrollment, and study documentation.

The role includes mentoring junior staff, collaborating with investigators, sponsors, and IRBs, and supporting business development and study start-up activities.