Clinical Research Coordinator

Clinical Research Coordinator Overview

• The Clinical Research Coordinator ensures compliance with GCP, ICH, HIPAA, and FDA regulations while managing assigned studies.
• Collaborates with clinical research teams to execute studies effectively and maintain high-quality standards.
• Screens patients for study enrollment, obtains consents, and conducts follow-up visits.
• Documents clinical data, performs lab procedures, and ensures proper handling of specimens.
• Maintains study logs, updates charts, and orders study-specific supplies as needed.
• Schedules study visits, conducts appointment reminders, and resolves monitoring issues promptly.
• Prepares for study start-up activities, including training and site initiation visits.
• Supports recruitment efforts, patient enrollment, and tracking to ensure study success.
• Maintains confidentiality and adheres to ALCOAC principles in all documentation practices.

Clinical Research Coordinator Key Responsibilities & Duties

• Screen patients for study eligibility and obtain informed consents effectively.
• Conduct patient follow-up visits and document clinical data accurately.
• Perform basic clinical procedures, including vitals, ECGs, and specimen handling.
• Enter data into EDC systems, resolve queries, and maintain study logs.
• Prepare study-specific supplies and ensure timely scheduling of study visits.
• Assist with study recruitment, patient enrollment, and tracking activities.
• Support site initiation visits and investigator meetings as required.
• Maintain effective communication with clients, team members, and external stakeholders.
• Ensure compliance with regulatory guidelines and confidentiality standards.

Clinical Research Coordinator Job Requirements

• Bachelor of Science degree or equivalent combination of education and experience required.
• Minimum of 1 year of clinical research or clinical experience; 2 years preferred.
• Proficiency in clinical procedures like vitals, EKGs, and phlebotomy highly desirable.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks.
• Proficiency with computer applications, electronic health records, and web-based systems.
• Effective communication skills and ability to work collaboratively with diverse teams.
• Ability to handle sensitive information confidentially and professionally.
• Bi-lingual proficiency in English and Spanish is a plus.
• Commitment to ethical practices and regulatory compliance in clinical research.