Lead Clinical Trial Coordinator

Nicklaus Children's Health System; Miami (FL); Presencial; USD 85.000 - 115.000; Jornada completa

Descripción de la vacante

Nicklaus Children's Health System is seeking a Senior Clinical Research Coordinator to manage day-to-day activities of complex pediatric trials under the Senior Manager of Clinical Trial Operations. The role ensures adherence to the protocol, GCP, IRB requirements, and sponsor expectations while coordinating data entry, regulatory documents, and site operations.

Responsibilities include subject recruitment, enrollment, follow-up, data management, and collaboration with investigators, sponsors,

Formación

• Bachelor's degree with 3.5+ years in research or 7+ years overall experience.
• CCR/CCRP/CRA certification beneficial.
• Bilingual in English/Spanish advantageous.
• Experience in pediatric hospital clinical research preferred.

Responsabilidades

• Assists management with business development efforts.
• Attends investigator meetings, pre-study visits, initiation meetings or coordinator meetings as appropriate.
• Collects and maintains accurate patient data for submission to Sponsor; coordinates collection and shipments of specimens as required by protocol.
• Communicates study objectives to hospital units and builds rapport with the Principal Investigator and Sponsor.
• Schedules and facilitates study monitor visits and communication between Principal Investigator and Sponsor.
• Maintains Research Finance Compliance documentation and reports to research finance staff.
• Interacts with patients and families to recruit subjects and ensure protocol compliance.
• Oversees patient enrollment and ensures timely enrollment across studies.
• Utilizes Good Clinical Practices; follows NCRI, AAHRPP, HIPAA, and FDA guidelines.
• Enters required data into CTMS and provides status updates to staff.
• Trains junior staff and maintains up-to-date electronic patient files in e-regulatory systems.
• Works adjusted hours to accommodate subject visits.
• Collaborates with investigators to recruit patients for available trials.

Conocimientos

Pediatric clinical research

Bilingual English/Spanish

GCP/IRB knowledge

Certification: CCRC/CCRP/CRA

Excellent communication

Educación

Bachelor's degree + 3.5+ years research

Associate's degree + 6+ years research

7+ years research experience

Herramientas

CTMS

eRegulatory systems

Hospital records/software

Descripción del empleo

Nicklaus Children's Health System is seeking a Senior Clinical Research Coordinator to manage day-to-day activities of complex pediatric trials under the Senior Manager of Clinical Trial Operations. The role ensures adherence to the protocol, GCP, IRB requirements, and sponsor expectations while coordinating data entry, regulatory documents, and site operations.

Responsibilities include subject recruitment, enrollment, follow-up, data management, and collaboration with investigators, sponsors,