Senior Clinical Trials Coordinator & Study Ops Lead

National Electrical Manufactures Assoc; Miami, Northern (FL, KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Nicklaus Children's Research Institute is seeking a Lead Clinical Research Coordinator CTO to independently manage multiple clinical studies, ensuring compliant execution and high-quality data collection. You will oversee enrollment, data management, and regulatory submissions while mentoring junior staff.

The role requires a nursing background (BSN preferred) and relevant certifications, with strong communication across investigators, sponsors, and regulatory authorities.

Qualifications

• Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience.
• Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 16 months in position

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 start-up data collection activities.
• Manages data collection and reporting for sponsors; maintains patient records.
• Registers and enrolls research participants and tracks eligibility.
• Aggregates CTMS data; runs weekly enrollment reports for management.
• Interacts with patients and families to recruit, screen, consent, and enroll.
• Manages regulatory submissions and confidentiality per policies.

Skills

Clinical research coordination

Regulatory compliance

CTMS data management

Bilingual English/Spanish

Mentoring/leadership

Education

Bachelor's degree in Nursing (BSN) preferred

Tools

CTMS

IRB submission platforms

Job description

Nicklaus Children's Research Institute is seeking a Lead Clinical Research Coordinator CTO to independently manage multiple clinical studies, ensuring compliant execution and high-quality data collection. You will oversee enrollment, data management, and regulatory submissions while mentoring junior staff.

The role requires a nursing background (BSN preferred) and relevant certifications, with strong communication across investigators, sponsors, and regulatory authorities.