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 pivotal 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 while working within a collaborative and innovative environment. The Clinical Research Coordinator will be responsible for supervising research activities, monitoring patient safety, and ensuring adherence to FDA regulations and ICH GCP guidelines.

Responsibilities

• Coordinate and manage clinical trials from initiation through completion, ensuring all phases comply with regulatory requirements.
• Supervise research staff and oversee daily trial operations, including patient recruitment, scheduling, and follow-up.
• Review and verify documentation such as consent forms, case report forms, and source documents for accuracy and completeness.
• Monitor patient progress by assessing vital signs, blood sampling, and other clinical assessments in accordance with study protocols.
• Ensure proper data collection, entry, management, and analysis using statistical software and EMR systems aligned with CDISC standards.
• Maintain compliance with HIPAA regulations and manage confidentiality of patient information throughout the study process.
• Conduct quality assurance checks to ensure adherence to FDA regulations, ICH GCP guidelines, and institutional policies.
• Collaborate with laboratory personnel for clinical laboratory testing, blood sampling, and specimen handling procedures.
• Prepare reports for regulatory agencies and sponsor updates related to study progress or adverse events.
• Stay current on clinical development trends, regulatory changes, and best practices in clinical trials management.

Experience

• Supervising experience in a clinical research setting or healthcare environment preferred.
• Proven experience managing clinical trials or working within clinical development projects.
• Strong knowledge of medical terminology, FDA regulations, HIPAA compliance, and ICH GCP standards.
• Experience with data collection, data management systems, EMR systems, and statistical software tools.
• Background in clinical laboratory procedures such as phlebotomy, blood sampling, vital signs monitoring, or nursing is advantageous.
• Familiarity with CDISC standards for data reporting is desirable.
• Certification such as an ICH GCP certificate from a recognized issuer for CA is preferred.
• Knowledge of clinical research processes including documentation review, compliance management, and research ethics is essential. This position offers an engaging opportunity for professionals committed to advancing medical science through meticulous research coordination while ensuring the highest standards of patient safety and regulatory compliance.

Job Types: Full-time, Part-time

Pay: $25.00 per hour

Expected hours: 25 – 40 per week

Work Location: In person