Clinical Research Coordinator

Total Health And Research Center; Miami (FL); On-site; USD 55,000 - 75,000; Full time

Job summary

Uloop Inc. in Miami, FL is seeking a dedicated Clinical Research Coordinator to oversee the planning, execution, and management of clinical trials, ensuring GCP compliance and FDA/HIPAA standards.

You will coordinate patient recruitment, data collection, and analysis, while supervising study activities. The ideal candidate has experience in clinical research coordination, strong knowledge of medical terminology, and the ability to lead cross-functional teams.

Qualifications

• Experience in clinical research coordination or trial management.
• Strong knowledge of GCP, FDA regulations, and medical terminology.
• Experience with patient monitoring, documentation review, and compliance.
• Ability to lead and collaborate with cross-functional teams.
• Familiarity with CDISC standards and data management is a plus.

Responsibilities

• Supervise day-to-day operations of clinical trials.
• Monitor patient progress and record adverse events.
• Review study documents for FDA/HIPAA compliance.
• Coordinate with cross-functional teams for effective communication.
• Conduct data collection, management, and analysis per CDISC standards.
• Maintain records and prepare for audits and inspections.
• Provide training on laboratory procedures and EMR usage.

Skills

Clinical Research

GCP guidelines

Team leadership

Education

Bachelor's degree in Life Sciences

Tools

SAS

EMR systems

CDISC

Job description

Job Overview

We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our team. In this role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. You will be responsible for coordinating all aspects of clinical research projects, from patient recruitment to data collection and analysis. The ideal candidate will possess strong supervisory experience and a solid understanding of clinical trials management.

Duties

• Supervise and manage the day-to-day operations of clinical trials, ensuring adherence to protocols and timelines.
• Monitor patient progress throughout the study, including vital signs assessment and documentation of adverse events.
• Review documentation for accuracy and compliance with FDA regulations and HIPAA standards.
• Collaborate with cross-functional teams to facilitate effective communication and coordination of clinical activities.
• Conduct data collection, management, and analysis using statistical software while adhering to CDISC standards.
• Maintain comprehensive records of study activities, including patient monitoring reports and research documentation.
• Ensure compliance with regulatory bodies by preparing for audits and inspections as needed.
• Provide training and support to staff on clinical laboratory procedures, phlebotomy techniques, and EMR systems usage.

Requirements

• Proven experience in clinical research coordination or management of clinical trials.
• Strong knowledge of medical terminology, clinical development processes, and GCP guidelines.
• Experience in documentation review, patient monitoring, and compliance management is essential.
• Understanding of FDA regulations governing clinical research practices.
• Previous experience in a clinical laboratory setting is a plus; phlebotomy skills are highly desirable.
• Ability to work collaboratively in a team environment while demonstrating strong leadership capabilities.

Work Authorization

Candidates must be legally authorized to work in the United States. We do not offer visa sponsorship at this time.

Relocation Support

This position does not include relocation assistance.

Start Date

Must be available to start within 2-4 weeks of job offer.