Clinical Research Coordinator

ClinLab Solutions Group; Miami (FL); On-site; USD 60,000 - 85,000; Full time

Job summary

ClinLab Solutions Group in Miami, FL is seeking a dedicated Clinical Research Coordinator for Phase I trials. You will work onsite with the PI and Site Director, ensuring informed consent, enrollment, and visit scheduling while upholding GCP standards.

You will maintain accurate source documents, manage regulatory files, and report adverse events and deviations in line with FDA requirements. Two to four years of CRC experience or CRC certification is expected.

Qualifications

• Two to four years of clinical research coordination experience or CRC certification.
• Phase I clinical trial experience required.
• Strong knowledge of GCP and ICH guidelines.
• Solid medical terminology background.
• Excellent verbal and written communication skills.
• Proficiency in Word, Excel, and CTMS.

Responsibilities

• Coordinate studies from start up through close out onsite.
• Review protocols and liaise with PI and Site Director.
• Screen, consent, enroll volunteers and schedule visits.
• Maintain source documents, regulatory files, and CRFs.
• Track adverse events and protocol deviations per FDA/GCP.

Skills

CRC experience

Phase I trials

GCP/ICH knowledge

Medical terminology

Communication skills

Microsoft Word

Microsoft Excel

Clinical trial systems

Tools

Word

Excel

CTMS

Job description

Join a growing clinical research organization in Miami, FL that runs Phase I through Phase IV trials across neuroscience and other high need therapeutic areas. This is an onsite role where you will coordinate studies from start up through close out, working closely with the Principal Investigator and Site Director. Phase I trial experience is required for this position.

Responsibilities:

• Review and understand each study protocol before start up, working closely with the PI and Site Director.
• Screen, consent, and enroll study volunteers, then schedule and manage their visits.
• Maintain accurate and complete study records, including source documents, regulatory files, and CRFs.
• Track and report adverse events and protocol deviations in line with GCP and FDA requirements.
• Communicate protocol related questions and updates to the sponsor and site leadership.
• Support subject recruitment efforts and maintain ongoing communication with referring providers.

Requirements:

• Two to four years of clinical research coordination experience or CRC certification.
• Phase I clinical trial experience required.
• Strong knowledge of GCP, ICH guidelines, and medical terminology.
• Excellent verbal and written communication skills.
• Proficiency in Word, Excel, and clinical trial management systems.