Clinical Research Coordinator

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.

• 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.

• 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.

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

This position does not include relocation assistance.

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