Clinical Research Coordinator

Job Summary
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this vital role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and maintaining the integrity of data collection. Your energetic approach will help drive innovative research forward, contributing to advancements in healthcare and patient outcomes. This paid position offers an exciting opportunity to work closely with multidisciplinary teams, coordinate complex studies, and make a meaningful impact in the clinical research field.

Responsibilities

• Coordinate all aspects of clinical trials from start-up through closeout, including participant recruitment, scheduling, and follow-up.
• Review and verify study documentation for accuracy, completeness, and regulatory compliance.
• Monitor patient progress by conducting vital signs assessments, blood sampling (phlebotomy), and recording clinical data accurately.
• Manage data collection and entry using electronic medical record (EMR) systems while ensuring adherence to CDISC standards for data formatting.
• Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other applicable protocols.
• Supervise research staff and collaborate with investigators to facilitate smooth trial operations.
• Conduct clinical laboratory procedures and analyze results to support study objectives.
• Maintain detailed documentation review processes, prepare reports, and support audits or inspections as needed.
• Oversee patient safety by monitoring adverse events and ensuring proper reporting procedures are followed.
• Utilize statistical software tools for data analysis to interpret research findings effectively.

Requirements

• Proven supervising experience in a clinical research or healthcare setting.
• Strong knowledge of clinical trials management, including FDA regulations and ICH GCP standards.
• Excellent understanding of medical terminology, clinical laboratory procedures, and blood sampling techniques.
• Experience with EMR systems, data management practices, and adherence to CDISC standards.
• Ability to review complex documentation thoroughly while maintaining attention to detail.
• Familiarity with clinical development processes and research methodologies.
• Certification in Good Clinical Practice (GCP) from a recognized issuer for California or equivalent certification is preferred.
• Knowledge of HIPAA compliance requirements related to patient privacy and data security.
• Skills in analysis using statistical software packages are advantageous.
• Effective communication skills for coordinating with multidisciplinary teams and ensuring protocol adherence. Join us as a Clinical Research Coordinator to be at the forefront of groundbreaking healthcare research! Your dedication will help shape the future of medicine while gaining invaluable experience in a fast-paced, rewarding environment dedicated to excellence in clinical trials management.

Pay: $16.00 - $18.00 per hour

Work Location: In person