Lead Clinical Research Coordinator, Trials Operations

Pscfl; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Nicklaus Children's Research Institute is seeking a Lead Clinical Research Coordinator to independently coordinate multiple studies under the Clinical Trials Office. You will ensure compliant conduct, manage subject recruitment, data management, and regulatory submissions while mentoring Coordinators and staff.

The role requires advanced knowledge of protocol requirements, CTMS data entry, and collaboration with investigators, sponsors, IRBs, and regulatory bodies to avoid delays and ensure

Qualifications

• Bachelor's degree or higher with 5 years of research experience or 9 years of research experience.
• SOCRA or ACRP certification required within 16 months in position.
• BSN and RN licensure strongly preferred.
• Bilingual in English/Spanish.
• Ability to train, guide, and mentor peers.

Responsibilities

• Serve as subject-matter expert for compliant conduct of studies.
• Facilitate communication between investigators and coordinators on technical matters.
• Oversee study conduct including data collection for start-up activities.
• Coordinate collection and shipments of specimens as required by protocol.
• Review study eligibility with PI/Sub-I and oversee enrollment.
• Register and enroll research participants and manage CTMS entries.
• Aggregate and report CTMS metrics for enrollment and portfolio updates.
• Communicate study status changes to CTMO and regulatory teams.
• Meet with management and researchers to discuss portfolio status.

Skills

Bachelor's Degree

RN licensure

Bilingual English/Spanish

Mentor peers

Communication

Data management

Regulatory compliance

Education

Bachelor's Degree or higher

SOCRA/ACRP certification

Tools

CTMS

Word processing

Scheduling software

Contact database

Job description

Nicklaus Children's Research Institute is seeking a Lead Clinical Research Coordinator to independently coordinate multiple studies under the Clinical Trials Office. You will ensure compliant conduct, manage subject recruitment, data management, and regulatory submissions while mentoring Coordinators and staff.

The role requires advanced knowledge of protocol requirements, CTMS data entry, and collaboration with investigators, sponsors, IRBs, and regulatory bodies to avoid delays and ensure