Clinical Research Coordinator

Overview

• Coordinate clinical research studies ensuring compliance with GCP, ICH, HIPAA, FDA regulations, and organizational SOPs.
• Collaborate with site teams to execute assigned studies effectively and efficiently.
• Screen and enroll patients, obtain consents, and manage follow-up visits.
• Perform clinical procedures such as vital signs, ECGs, and specimen handling.
• Ensure accurate documentation and data entry in electronic data capture systems.
• Maintain confidentiality and adhere to ALCOAC principles in all documentation.
• Support study start-up activities, including training and technology setup.
• Assist with patient recruitment and enrollment as needed.
• Contribute to a collaborative and professional work environment.

Key Responsibilities & Duties

• Screen patients for study eligibility and obtain informed consents.
• Schedule and conduct patient visits, ensuring protocol adherence.
• Perform clinical procedures including vital signs, ECGs, and phlebotomy.
• Document patient data accurately and resolve queries in EDC systems.
• Prepare and maintain study-specific supplies and logs.
• Coordinate monitoring visits and address issues promptly.
• Report adverse events and deviations to sponsors and IRBs.
• Assist with study recruitment and enrollment processes.
• Ensure compliance with HIPAA and confidentiality standards.

Job Requirements

• Associate’s degree or equivalent combination of education and experience.
• Minimum of 1 year of clinical research or clinical experience required.
• Proficiency in clinical procedures such as vitals, EKGs, and phlebotomy.
• Strong organizational, communication, and interpersonal skills.
• Ability to handle sensitive information confidentially and professionally.
• Proficiency with Microsoft applications and electronic health records.
• Bilingual proficiency in English and Spanish is a plus.
• Self-motivated with a strong work ethic and ability to work independently.
• Ability to adapt to workload changes and prioritize tasks effectively.