Clinical Research Coordinator

Job Summary
We are seeking a dynamic and dedicated Clinical Research Coordinator to join our team and drive forward innovative clinical trials. In this vital role, you will oversee the daily operations of clinical studies, ensuring compliance with regulatory standards and maintaining meticulous documentation. Your energetic approach will facilitate smooth trial execution, patient engagement, and data integrity, ultimately contributing to groundbreaking medical advancements. This paid position offers an exciting opportunity to be at the forefront of clinical research, supporting the development of new therapies and treatments.

Responsibilities

• Coordinate all aspects of clinical trials from start-up through closeout, ensuring adherence to protocols, FDA regulations, ICH GCP guidelines, and institutional policies.
• Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure participant safety and protocol compliance.
• Review medical records, laboratory results, and other documentation for accuracy and completeness in accordance with study requirements.
• Conduct patient assessments including vital signs, blood sampling (phlebotomy), and other clinical procedures while maintaining strict confidentiality under HIPAA regulations.
• Utilize electronic medical record (EMR) systems for data entry, management, and reporting; ensure data collection aligns with CDISC standards for clinical research data.
• Supervise research staff and coordinate with multidisciplinary teams to facilitate efficient trial progress.
• Prepare detailed reports, monitor study progress, and assist in audits or inspections by regulatory agencies such as the FDA.
• Ensure compliance with clinical laboratory standards and maintain up-to-date knowledge of clinical development processes.

Skills

• Proven supervising experience in a clinical research or healthcare setting with strong leadership capabilities.
• Extensive knowledge of clinical trials management including protocol review, patient monitoring, and data collection procedures.
• Familiarity with medical terminology, blood sampling techniques (phlebotomy), vital signs measurement, and clinical laboratory practices.
• Proficiency in using statistical software for data analysis and interpretation related to clinical studies.
• Deep understanding of FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and compliance management practices.
• Experience working with EMR systems and research databases; ability to manage data accurately according to CDISC standards.
• Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent; ICH GCP certificate preferred.
• Strong analytical skills with attention to detail in documentation review and data management tasks.
• Background in nursing or related healthcare fields is advantageous; clinical laboratory experience is highly valued. Join us to be part of a passionate team committed to advancing healthcare through meticulous research coordination!

Pay: $27.00 - $31.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person