Clinical Research Coordinator

Overview

• Coordinate clinical research studies ensuring compliance with GCP, ICH, HIPAA, FDA regulations, and organizational SOPs.
• Collaborate with research teams to execute study protocols and maintain accurate documentation.
• Perform patient screening, consent collection, and follow-up visits for study enrollment.
• Document study data in electronic data capture systems and resolve queries efficiently.
• Conduct basic laboratory procedures including specimen collection, processing, and shipping.
• Ensure timely reporting of adverse events, deviations, and compliance issues to sponsors and IRB.
• Maintain confidentiality of patient and organizational information adhering to HIPAA guidelines.
• Support study recruitment, patient enrollment, and tracking activities as needed.

Key Responsibilities & Duties

• Screen patients for study eligibility and obtain informed consent for participation.
• Schedule and conduct patient follow-up visits ensuring protocol adherence.
• Document patient information in clinical charts and electronic systems accurately.
• Perform clinical procedures such as vital signs measurement and ECG collection.
• Manage study-specific supplies and maintain organized study logs and files.
• Coordinate monitoring visits and address issues promptly to ensure study progress.
• Prepare for site initiation visits and investigator meetings, completing required training.
• Ensure effective communication with clients, team members, and external stakeholders.

Job Requirements

• Associate degree or equivalent education and experience in clinical research or healthcare.
• Minimum of 1 year of clinical research or clinical experience; 2 years preferred.
• Proficiency in basic clinical procedures such as phlebotomy, vital signs, and ECGs.
• Strong organizational skills and attention to detail for managing study documentation.
• Effective communication and interpersonal skills for patient and team interactions.
• Ability to handle sensitive information confidentially and professionally.
• Proficiency in computer applications including Microsoft Office and electronic health records.
• Bilingual proficiency in English and Spanish is a plus.