Senior Clinical Trial Coordinator, Pediatric Research

Nicklaus Children's Health System; Miami (FL); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

Nicklaus Children’s Health System in Miami, FL is seeking a Senior Clinical Research Coordinator to manage day-to-day activities of complex pediatric trials. You will ensure protocol adherence, GCP/IRB compliance, and oversee data management and regulatory documentation.

Responsibilities include recruitment, data entry into CTMS, protocol amendments, and training junior staff. A background in pediatric hospital research, certifications, and bilingual English/Spanish are highly valued.

Competenze

• 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 (PI Initiated, IND and/or Device) clinical trials.
• Experience working on clinical trials, interventional studies all phases.
• Bilingual in English/Spanish.
• Excellent communication skills in working with both children and adults.
• Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.
• Knowledge of protocols and its process.
• Experience with software applications including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.
• Experience with relevant hospital equipment for each clinical trial project.
• Availability to work adjusted hours to accommodate subject visits.

Mansioni

• Assists management with business development efforts.
• Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
• Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol.
• Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance.
• Communicates with the Sponsor or their representatives. Schedules & facilitates study monitor visits and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives.
• Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff.
• Interacts with patients and families to recruit study subjects and ensures compliance with the protocol.
• Responsible for speedy and adequate patient enrollment as determined by Research Management in all assigned studies.
• Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.
• Follows NCRI’s Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.
• Enters required data into CTMS.
• Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS.
• Assists with training initiatives (including mentoring) with new and junior research staff (Research Assistants, Data Assistants and Research Volunteers).
• Keeps electronic patient files and required documents up-to-date within e-regulatory system.
• Works adjusted hours to accommodate subject visits.
• Works on clinical trials, interventional studies all phases.
• Collaborates with study investigators to screen and recruit patients to available clinical trials.

Conoscenze

Pediatric clinical research

Clinical research certification

IATA certification

Interventional trials experience

Bilingual English/Spanish

Strong communication skills

Excellent organizational skills

Protocol knowledge

Regulatory software tools

Flexible hours

Formazione

Bachelor's degree + 3.5 years experience

Associate's degree + 6 years experience

7 years research experience

Descrizione del lavoro

Nicklaus Children’s Health System in Miami, FL is seeking a Senior Clinical Research Coordinator to manage day-to-day activities of complex pediatric trials. You will ensure protocol adherence, GCP/IRB compliance, and oversee data management and regulatory documentation.

Responsibilities include recruitment, data entry into CTMS, protocol amendments, and training junior staff. A background in pediatric hospital research, certifications, and bilingual English/Spanish are highly valued.