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.