Senior Clinical Research Coordinator - GI Research

About This Role

The Senior Clinical Research Coordinator supports and coordinates daily clinical trial activities, playing a critical role in study conduct, particularly within gastrointestinal (GI) and hepatology novel therapies. This position suits an experienced professional who can manage industry-sponsored trials, lead patient recruitment, and ensure protocol adherence.

Responsibilities

• Administratively and clinically manage industry-sponsored clinical trials, including problem-solving, communication, and protocol management
• Lead patient recruitment activities, such as performing chart reviews, discussing protocols with patients, and verifying informed consent documentation to meet enrollment targets on assigned studies
• 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, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms
• 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, and PI throughout the 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
• Support other site staff with coaching on best practices for clinical trials processes, patient interactions, and project management
• Work closely with Principal Investigators and referring positions to build understanding and enthusiasm for research opportunities for patients
• Participate actively in communication of status and results to management
• Contribute and implement ideas to improve site performance
• Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations to management to resolve the situations
• 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