Clinical Research Coordinator

Clinical Research Coordinator Overview

• The Clinical Research Coordinator ensures the execution of clinical studies in compliance with regulatory standards and protocols.
• Collaborate with clinical research teams to maintain study integrity and patient confidentiality.
• Perform patient screening, consent processes, and follow-up visits to ensure study compliance.
• Document patient interactions and study data accurately in electronic systems.
• Conduct basic lab procedures, including specimen collection, storage, and shipping.
• Maintain effective communication with investigators, sponsors, and team members.
• Support study start-up activities, including training and technology setup.
• Ensure compliance with HIPAA, GCP, and FDA regulations throughout the study.
• Contribute to study recruitment, enrollment, and tracking as required.

Clinical Research Coordinator Key Responsibilities & Duties

• Screen and enroll patients for clinical studies while ensuring informed consent.
• Document and manage patient data in compliance with study protocols.
• Perform clinical procedures such as vital signs, ECGs, and phlebotomy.
• Coordinate study visits, reminders, and follow-ups for enrolled patients.
• Maintain study-specific supplies and ensure proper documentation of adverse events.
• Assist with site initiation visits and investigator meetings as needed.
• Ensure timely reporting of deviations, adverse events, and compliance issues.
• Collaborate with sponsors and IRBs to maintain study integrity.
• Support recruitment efforts and maintain positive communication with stakeholders.

Clinical Research Coordinator Job Requirements

• Bachelor of Science degree with a minimum of 1 year of clinical research experience.
• Proficiency in performing clinical procedures such as blood pressure, vitals, and EKGs.
• Strong organizational and communication skills with attention to detail.
• Experience with electronic health records and data entry systems.
• Ability to manage multiple tasks and adapt to changing priorities effectively.
• Knowledge of GCP, FDA regulations, and HIPAA compliance standards.
• Bi-lingual proficiency in English and Spanish is preferred.
• Self-motivated and dependable with a professional demeanor.
• Ability to handle sensitive information confidentially and professionally.