Clinical Research Coordinator II

About This Role

This role involves supporting, facilitating, and coordinating the daily activities of clinical trials, playing a critical part in their execution. The Clinical Research Coordinator II will administratively and clinically manage industry-sponsored clinical trials, overseeing complex study visits and related tasks with minimal supervision.

Responsibilities

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management
• Manage a full schedule of complex study visits and corresponding tasks with minimal direction
• Lead patient recruitment activities, including performing chart reviews, discussing protocols with patients, and verifying informed consent documentation to meet enrollment targets
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs, and perform ECGs
• Perform blood draws, process, and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis
• Complete and maintain documentation study files including consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms
• Maintain high quality data entry within established timelines
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, central Iterative Health team, and PI throughout the study
• Resolve routine sponsor and CRO issues independently
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Contribute to status updates to management
• Contribute and implement ideas to improve site performance
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assist Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperate with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
• Complete and maintain case report forms per FDA guidelines, and review them against the patient