Clinical Research Assistant - RN - Webster, TX

Responsibilities

• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Monitor patients’ IV medications and tubing.
• Monitor patients during infusion and discharge patients as policies indicate.
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
• Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Schedule and prepare for monitor visits
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
• Perform quality work within deadlines with or without direct supervision

Requirements

• By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
• Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

Experience