Senior Clinical Trials Coordinator & Study Lead

Nicklaus Children's Health System; Miami (FL); On-site; USD 75,000 - 110,000; Full time

Job summary

Nicklaus Children's Health System in Miami, FL is seeking a Lead Clinical Research Coordinator CTO to independently coordinate multiple clinical studies within the Clinical Trials Office, ensuring compliant conduct, recruitment, data entry, and regulatory documentation while guiding a 팀 of coordinators and support staff.

You will oversee start-up activities, data reporting, CTMS data entry within 72 hours, and communication with investigators, IRBs, sponsors, and regulatory authorities.

Qualifications

• Bachelor's degree (or higher) and 5 years of research experience (or 9 years).
• Clinical research certification through SOCRA or ACRP within 16 months in position.
• RN licensure or BSN strongly preferred.

Responsibilities

• Serves as subject-matter expert for compliant conduct of assigned studies.
• Facilitates communication between investigators and coordinators on technical matters.
• Oversees study conduct including all support data collection for startup activities.
• Oversees data collection, maintenance, and reporting for submissions to sponsors; coordinates specimens as required.
• Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies.
• Oversees study registration, patient screening/enrollment, and overall study requirements.
• Registers and enrolls research participants.
• Aggregates, tracks, trends, and reports research study and enrollment data.
• Interacts with patients and families to recruit and enroll study subjects while ensuring protocol compliance.
• Complies with research finance compliance policies including time and effort reporting for grants.
• Submits protocol amendments to IRB and notifies CTMS support for digitization.
• Enters Research Patient information into CTMS within 72 hours of enrollment/visit.
• Pre-screens potential participants and enters CTMS data within real time or within 24 hours.
• Compiles CTMS metrics data for SAC CTO slides; runs weekly enrollment reports.
• Updates study statuses in CTMS and communicates enrollment changes to stakeholders.
• Attends meetings with Research management and PI/Sub-Is to discuss portfolio and patient status.

Skills

Bilingual English/Spanish

Excellent communication

Time management

Detail-oriented

Team collaboration

Regulatory compliance

Data management

Mentorship

Education

Bachelor's Degree or higher

SOCRA/ACRP certification

BSN or RN licensure preferred

Tools

Word processing

Scheduling software

CTMS

Electronic data capture (EDC)

Microsoft Office

Database software

Job description

Nicklaus Children's Health System in Miami, FL is seeking a Lead Clinical Research Coordinator CTO to independently coordinate multiple clinical studies within the Clinical Trials Office, ensuring compliant conduct, recruitment, data entry, and regulatory documentation while guiding a 팀 of coordinators and support staff.

You will oversee start-up activities, data reporting, CTMS data entry within 72 hours, and communication with investigators, IRBs, sponsors, and regulatory authorities.