Clinical Research Coordinator

Job Overview
We are seeking a highly organized and detail-oriented Clinical Research Coordinator to manage and oversee clinical trials within our research facility. This role involves coordinating study activities, ensuring compliance with regulatory standards, and maintaining accurate documentation. The ideal candidate will have experience in clinical trials management, familiarity with FDA regulations, and a strong understanding of medical terminology and data management systems. The Clinical Research Coordinator plays a vital role in advancing clinical development and ensuring the integrity of research data while providing exceptional support to research teams and participants.

Duties

• Coordinate and oversee all aspects of clinical trials, including patient recruitment, enrollment, and monitoring
• Ensure adherence to ICH Good Clinical Practice (GCP) standards and FDA regulations
• Review and verify documentation for accuracy, completeness, and compliance
• Collect, manage, and analyze clinical data using EMR systems, statistical software, and CDISC standards
• Monitor patient vital signs, blood sampling, phlebotomy procedures, and other clinical assessments
• Supervise research staff and provide training on protocol procedures and compliance management
• Maintain detailed records of study activities, adverse events, and regulatory documentation
• Conduct regular audits to ensure trial compliance with HIPAA regulations and institutional policies
• Collaborate with laboratory personnel for clinical laboratory testing and analysis
• Prepare reports for regulatory submissions and research publications as needed

Requirements

• Proven supervising experience in clinical trials or research settings
• Strong knowledge of clinical trials management, FDA regulations, ICH GCP standards, and HIPAA compliance
• Experience with EMR systems, data collection tools, statistical software, and CDISC standards
• Background in nursing, phlebotomy, or clinical laboratory work is highly desirable
• Excellent documentation review skills and attention to detail
• Ability to monitor patient vital signs accurately and perform blood sampling procedures safely
• Familiarity with clinical development processes and research protocols
• Certification such as ICH GCP certificate from a valid issuer for CA is preferred
• Strong analysis skills for interpreting clinical data and ensuring protocol adherence
• Effective communication skills for collaborating with multidisciplinary teams

This position offers an opportunity to contribute significantly to groundbreaking clinical research projects while working within a dynamic team dedicated to advancing healthcare solutions.

Pay: $28.30 - $34.08 per hour

Location:

• United States (Required)

Work Location: Remote