Clinical Research Coordinator

Job Overview
We are seeking a dedicated and highly organized Clinical Research Coordinator to join our dynamic research team. The ideal candidate will possess a strong background in clinical trials management (GI preferred), patient monitoring, and data collection, with a keen eye for detail and compliance. As a Clinical Research Coordinator, you will oversee the daily operations of clinical studies, ensure adherence to regulatory standards, and facilitate effective communication among research teams, participants, and stakeholders. This role offers an exciting opportunity to contribute to innovative medical research that advances patient care and scientific knowledge.

Responsibilities

• Coordinate all aspects of clinical trials from initiation through completion, including participant recruitment, screening, and enrollment.
• Monitor patient progress throughout the study period, ensuring safety and adherence to protocol.
• Review and verify clinical documentation for accuracy, completeness, and compliance with FDA regulations and ICH GCP standards.
• Manage data collection processes using electronic medical record (EMR) systems and ensure data integrity according to CDISC standards.
• Conduct patient assessments, including vital signs, blood sampling, and other clinical procedures such as phlebotomy.
• Collaborate with clinical laboratories to process samples accurately while maintaining proper documentation.
• Ensure compliance with HIPAA regulations and maintain confidentiality of patient information at all times.
• Prepare reports for regulatory submissions and audit readiness by reviewing documentation thoroughly.

Experience

• Proven experience in clinical trials management or coordination within a healthcare or research setting.
• Strong knowledge of medical terminology, FDA regulations, ICH GCP guidelines, and HIPAA compliance requirements.
• Hands-on experience with EMR systems, clinical laboratory procedures, blood sampling techniques, and vital signs measurement.
• Familiarity with clinical development processes and data management practices aligned with CDISC standards.
• Certification such as an ICH GCP certificate from a recognized issuer is highly desirable;

Pay: $20.00 - $25.00 per hour

Benefits:

• 401(k)
• Flexible schedule
• Paid time off
• Professional development assistance

Application Question(s):

• Are you willing to cross-train in other positions, like front desk?
• What is your desired pay?

Experience:

• Clinical research: 2 years (Preferred)

Work Location: Hybrid remote in Suwanee, GA 30024