Onsite Phase I 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

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.