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 play a vital role in coordinating all aspects of clinical studies, ensuring compliance with regulatory standards, and maintaining accurate documentation. This position offers an opportunity to contribute to groundbreaking medical research and improve patient outcomes through meticulous trial management and data collection.

Responsibilities

• Coordinate and oversee clinical trial activities in accordance with FDA regulations, Good Clinical Practice (GCP), and HIPAA guidelines.
• Manage patient recruitment, screening, enrollment, consent, and monitoring throughout the trial process.
• Review and verify documentation, including informed consent forms, case report forms, and other study-related records.
• Collect, record, and manage clinical data accurately using EMR systems and adhere to CDISC standards for data management.
• Conduct patient medical photography and potentially sample handling and storage.
• Ensure compliance with clinical development protocols and regulatory requirements during all phases of trials.
• Analyze collected data using statistical software to support study findings and prepare reports for review.
• Maintain detailed records of study activities, adverse events, and protocol deviations for audit purposes.
• Assist in training new staff on clinical trial procedures and documentation review processes.

Skills

• Proven experience in a clinical research setting is preferred.
• General knowledge of clinical trials management, including FDA regulations, GCP, HIPAA compliance, and CDISC standards.
• Understanding of medical terminology.
• Excellent documentation review skills with attention to detail for accuracy and regulatory compliance.
• Ability to monitor patients effectively while maintaining confidentiality under HIPAA guidelines.
• Strong analytical skills for data collection, analysis, and interpretation within clinical research projects.
• Thorough proficiency in Microsoft suite core productivity tools (e.g. Word, PowerPoint, Excel). Proficiency with EMR systems, data management tools, and statistical software is a plus.

Job Type: Part-time

Work Location: In person