clinical research Coordinator

Overview

• Coordinate clinical research studies ensuring compliance with GCP, ICH, HIPAA, FDA regulations, and SOPs.
• Collaborate with research teams to facilitate patient screening, enrollment, and follow-up visits.
• Maintain accurate documentation in clinic charts and electronic data capture systems.
• Perform basic lab procedures including specimen collection, centrifuge operation, and shipping.
• Ensure timely reporting of adverse events and non-compliance to relevant staff.
• Assist in study recruitment, patient enrollment, and tracking as required.
• Prepare for site initiation visits and investigator meetings, completing required training.
• Maintain confidentiality of patient and company information, adhering to HIPAA guidelines.

Key Responsibilities & Duties

• Screen patients for study eligibility and obtain informed consents.
• Document patient interactions and study data in electronic systems.
• Perform clinical procedures such as vital signs, ECGs, and phlebotomy.
• Coordinate specimen accountability, storage, and shipment as per protocol.
• Schedule study visits and conduct appointment reminders for participants.
• Resolve monitoring visit issues promptly and effectively.
• Maintain study-specific supplies and update logs and charts.
• Ensure investigator reviews study-related reports and patient results timely.

Job Requirements

• Bachelor of Science degree required; medical assistant diploma or equivalent preferred.
• Minimum 2 years of clinical research or clinical experience; 3 years preferred.
• Proficiency in clinical procedures such as vitals, EKGs, and phlebotomy.
• Strong organizational skills and attention to detail essential.
• Proficiency with computer applications and electronic health records required.
• Effective written and verbal communication skills necessary.
• Ability to manage multiple tasks and adapt to changing priorities.
• Professionalism, integrity, and confidentiality in handling sensitive information.