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).
Requirements
- Must be able to perform protocol-specific clinical tasks as trained and delegated (e.g., vital signs, ECGs, PFTs)
- Must accurately collect, document, and enter participant data in source records and EDC systems
- Must assist with phlebotomy, sample processing, and preparation/shipment of biological specimens in accordance with protocol and IATA requirements
- Must support study visits by preparing participant charts, lab kits, requisitions, and required documentation
- Must maintain clinical supply inventory, including PPE, exam room, and lab supplies; monitor stock levels and coordinate replenishment
- Must ensure exam rooms, lab spaces, and equipment are clean, organized, well-maintained, and visit-ready; maintain equipment logs and temperature records
- Must assist with participant scheduling, phone screenings, follow-up calls, and visit reminders
- Must support regulatory and study documentation filing, organization, and archiving in compliance with GCP, site SOPs, and sponsor requirements
- Must collaborate with Clinical Research Coordinators and clinical staff to ensure protocol adherence and regulatory compliance
- Must complete all required training (e.g., GCP, OSHA, IATA, site SOPs)
Additional Information
- Prioritizes the safety and well-being of all study participants
- Upholds the integrity of the study through collaborative efforts with the research team
