Clinical Research Coordinator

Overview

• Coordinate clinical research studies ensuring compliance with GCP, ICH, HIPAA, FDA regulations, and SOPs.
• Screen patients for study enrollment and manage patient consents and follow-up visits.
• Document clinical data in source charts and electronic data capture systems.
• Perform basic lab procedures including specimen collection, centrifuge operation, and shipping.
• Maintain and update study-specific logs, charts, and supplies inventory.
• Schedule study visits, conduct appointment reminders, and assist with recruitment efforts.
• Prepare for site initiation visits and investigator meetings as required.
• Ensure confidentiality of patient and company information in compliance with HIPAA guidelines.

Key Responsibilities & Duties

• Screen and enroll patients in clinical studies, ensuring informed consent and adherence to protocols.
• Perform and document clinical procedures such as vital signs, EKGs, and phlebotomy.
• Maintain accurate and timely documentation of adverse events and deviations.
• Coordinate with sponsors and IRBs for study-related reporting and compliance.
• Manage study-specific supplies and ensure readiness for study activities.
• Conduct monitoring visits and resolve issues promptly to maintain study integrity.
• Assist with technology setup and training for study-specific requirements.
• Collaborate effectively with team members and external stakeholders to achieve study objectives.

Job Requirements

• Associate degree or equivalent combination of education and experience required.
• Minimum of 1 year of clinical research or clinical experience; 3 years preferred.
• Proficiency in performing clinical procedures such as vitals, EKGs, and phlebotomy.
• Strong organizational skills and attention to detail for managing study documentation.
• Proficiency with computer applications including Microsoft Office and electronic health records.
• Effective communication and interpersonal skills for collaboration and patient interaction.
• Ability to handle sensitive information confidentially and professionally.
• Bilingual proficiency in English and Spanish is a plus.