Senior Clinical Trials Coordinator - Lead Research Ops

Nicklaushealth; Sunset Corners (FL); On-site; USD 90,000 - 140,000; Full time

Job summary

Nicklaus Children's Research Institute seeks a Lead Clinical Research Coordinator CTO to coordinate multiple clinical studies, ensuring compliant conduct, patient enrollment, data management, and regulatory submissions. You will mentor Coordinators and Research Assistants while liaising with investigators, IRBs, sponsors, CROs, and authorities.

The role requires advanced knowledge of protocols, CTMS, and data reporting, with strong communication skills and bilingual English/Spanish abilities

Qualifications

• Bachelor's degree and 5+ years of research experience or 9+ years of research experience.
• Clinical research certification (SOCRA/ACRP) required within 16 months of start date.
• Bilingual English/Spanish preferred.

Responsibilities

• Serve as subject-matter expert for compliant conduct of studies.
• Coordinate communication between investigators and coordinators on technical matters.
• Oversee study conduct, data collection, and study start-up activities.
• Manage patient data collection, submissions to sponsors, and specimen shipments as required by protocol.
• Verify study eligibility and enrollment with PI/Sub-Is.
• Oversee patient screening/enrollment and study requirements.
• Register and enroll research participants.
• Aggregate and report CTMS metrics and weekly enrollment reports.
• Maintain CTMS updates and communicate changes to CTM staff and CTO management.
• Attend meetings to discuss research portfolio and patient status.

Skills

Leadership

Regulatory compliance

Data management

Study coordination

Recruitment and enrollment

Team mentorship

IRB/Regulatory submissions

Communication skills

Bilingual English/Spanish

Time management

Education

Bachelor's Degree

SOCRA/ACRP certification

Tools

CTMS

Electronic Health Records

Job description

Nicklaus Children's Research Institute seeks a Lead Clinical Research Coordinator CTO to coordinate multiple clinical studies, ensuring compliant conduct, patient enrollment, data management, and regulatory submissions. You will mentor Coordinators and Research Assistants while liaising with investigators, IRBs, sponsors, CROs, and authorities.

The role requires advanced knowledge of protocols, CTMS, and data reporting, with strong communication skills and bilingual English/Spanish abilities