Clinical Research Coordinator

Job Summary

We are seeking a highly organized and detail-oriented Clinical Research Coordinator to oversee and manage clinical trials within our research facility. The ideal candidate will be responsible for coordinating all aspects of clinical studies, ensuring compliance with regulatory standards, and maintaining accurate documentation. This role offers an excellent opportunity to contribute to groundbreaking medical research while working in a collaborative and dynamic environment. Candidates with supervising experience, strong knowledge of clinical trials management, and familiarity with regulatory guidelines will thrive in this position.

Responsibilities

• Coordinate and oversee clinical trial activities in accordance with FDA regulations, ICH GCP standards, and HIPAA compliance.
• Supervise research staff and ensure adherence to study protocols, timelines, and quality standards.
• Manage patient recruitment, screening, enrollment, and monitoring throughout the study duration.
• Collect, review, and manage data accurately using EMR systems and adhere to CDISC standards for data management.
• Conduct patient assessments including vital signs, blood sampling, phlebotomy, and monitoring for adverse events.
• Review documentation for completeness, accuracy, and regulatory compliance; prepare reports for regulatory submissions.
• Ensure proper training of staff on clinical laboratory procedures, blood sampling techniques, and use of statistical software.
• Maintain compliance with FDA regulations, ICH GCP guidelines, and institutional policies related to clinical development.
• Facilitate communication between sponsors, investigators, and regulatory bodies to ensure smooth trial operations.
• Assist in the development of study protocols and case report forms while ensuring adherence to research standards.

Qualifications

• Proven supervising experience in a clinical research setting or related healthcare environment.
• Strong knowledge of clinical trials management, FDA regulations, ICH GCP certification (or equivalent), and HIPAA compliance.
• Experience with clinical laboratory procedures including blood sampling and phlebotomy.
• Familiarity with EMR systems, data collection tools, statistical software, and CDISC standards.
• Excellent understanding of medical terminology and clinical development processes.
• Ability to review complex documentation accurately and manage multiple projects simultaneously.
• Strong analysis skills with attention to detail in data management and compliance oversight.
• Relevant certifications such as GCP certification from a recognized issuer for CA are preferred; valid CA-issued GCP certificate is required if applicable.
• Background in nursing or related healthcare fields is advantageous; experience with clinical research or laboratory work is preferred. This position offers an engaging environment dedicated to advancing medical science through meticulous research practices while supporting professional growth within the field of clinical development.

Job Type: Full-time

Pay: $26.00 - $30.00 per hour

Work Location: In person