Clinical Research Assistant

Job Description

The Clinical Research Assistant (RA) supports the daily execution of clinical trial activities under the guidance of site leadership, the Principal Investigator (PI), and the clinical research staff. While the PI oversees the conduct of the study and the Clinical Research Coordinator (CRC) manages its day-to-day operations, the Research Assistant plays a key supporting role in ensuring protocol compliance and data quality. Through collaborative efforts with the research team, the Research Assistant helps uphold the integrity of the study and prioritizes the safety and well-being of all study participants.

Essential Duties and Responsibilities:

• Maintain clinical supply inventory, including PPE, exam room, and lab supplies; monitor stock levels and coordinate replenishment.
• Ensure exam rooms, lab spaces, and equipment are clean, organized, well-maintained, and visit-ready; maintain equipment logs and temperature records.
• Assist with phlebotomy, sample processing, and preparation/shipment of biological specimens in accordance with protocol and IATA requirements.
• Support study visits by preparing participant charts, lab kits, requisitions, and required documentation.
• Perform protocol-specific clinical tasks as trained and delegated (e.g., vital signs, ECGs, PFTs).
• Accurately collect, document, and enter participant data in source records and EDC systems; assist with query resolution and eDiary reconciliation.
• Assist with participant scheduling, phone screenings, follow-up calls, and visit reminders.
• Support regulatory and study documentation filing, organization, and archiving in compliance with GCP, site SOPs, and sponsor requirements.
• Collaborate with Clinical Research Coordinators and clinical staff to ensure protocol adherence and regulatory compliance.
• Complete all required training (e.g., GCP, OSHA, IATA, site SOPs).