Clinical Research Coordinator

Job Summary
We are seeking a dedicated and detail-oriented Clinical Research Coordinator to oversee the planning, execution, and management of clinical trials. The ideal candidate will possess a strong background in clinical research processes, including trial management, regulatory compliance, and patient monitoring. As a vital member of our research team, you will ensure the integrity of data collection, adherence to protocols, and compliance with regulatory standards such as FDA regulations and ICH Good Clinical Practice (GCP). This role offers an opportunity to contribute to innovative medical research that advances patient care and treatment options.

Duties

• Coordinate all aspects of clinical trials from initiation through closeout, ensuring adherence to study protocols and regulatory requirements.
• Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure accurate data collection and participant safety.
• Review and verify documentation for accuracy, completeness, and compliance with study protocols and regulatory standards.
• Utilize electronic medical record (EMR) systems for data entry, management, and reporting purposes.
• Ensure compliance with HIPAA regulations to protect patient confidentiality throughout all phases of research.
• Able to draw and Conduct blood sampling, vital signs measurement, and other clinical procedures in accordance with protocol specifications.
• Maintain detailed records of study activities, adverse events, and protocol deviations while preparing reports for regulatory submissions.
• Stay current with FDA regulations, ICH GCP guidelines, CDISC standards (Clinical Data Interchange Standards Consortium), and other relevant compliance requirements.

Qualifications

• Proven experience supervising clinical research projects or trials within healthcare or academic settings.
• Strong knowledge of clinical trials management, including patient monitoring and data collection methodologies.
• Proficiency in medical terminology, clinical laboratory procedures, and phlebotomy techniques.
• Familiarity with EMR systems, data management tools, and statistical software used in clinical research analysis.
• Certification in Good Clinical Practice (GCP) from a recognized issuer such as the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Understanding of FDA regulations governing clinical trials and compliance management practices.
• Experience working with clinical laboratories or conducting blood sampling procedures is highly desirable.
• Excellent organizational skills with attention to detail for documentation review and quality assurance processes.
• Effective communication skills to coordinate with research teams, healthcare providers, and regulatory bodies. Join our team to advance groundbreaking medical research through meticulous coordination and unwavering commitment to excellence!
• Team Player, willing to learn and grow.
• Phlebotomy and/ or Medical Assistant License, able to draw blood and work in the lab.

Pay: $20.00 - $32.00 per hour

Benefits:

• Flexible schedule
• Paid time off

Work Location: In person