Clinical Research Coordinator

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across the US and Europe accelerating the path to market for GI and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services.

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.

Reports To:

Manager, Clinical Research

Job Summary: The Clinical Research Coordinator coordinates and administers study-related activities and ensures regulatory requirements are followed, including adherence to good clinical practices (GCPs) and protection of human subjects. Conducts clinical drug trials in compliance with regulatory standards, sponsor requirements, patient safety, confidentiality, and high professional standards.

FLSA: Non-Exempt

Supervisory Responsibility: This position has no supervisory responsibilities.

• Administratively and clinically manage industry-sponsored clinical trials.
• Adhere to Research SOPs, Good Clinical Practices, and study protocols.
• Assist in patient recruitment by performing detailed chart reviews and patient interviews.
• Discuss study protocols with patients and verify informed consent documentation.
• Review medical history against inclusion/exclusion criteria.
• Perform blood draws, process and ship specimens per study protocol and IATA regulations.
• Schedule patient visits and procedures per protocol requirements.
• Dispense study medication, collect vital signs, and perform ECGs.
• Assist with routine data verification and quality control to ensure data integrity.
• Complete and maintain case report forms per FDA guidelines and verify against patient records for accuracy.
• Function in a clinical role by conducting clinical research studies.
• Monitor patients and provide information to medical staff to assure optimal outcomes.
• Develop concise research study information/tools for staff education and patient recruitment.
• Maintain protocol and regulatory compliance for studies in the research area.
• Act as a resource for staff regarding investigational issues or guidelines.
• Coordinate the availability and distribution of medications for patients in a timely manner.
• Perform phlebotomy for lab work as required and complete all necessary forms.
• Educate patients in all aspects of the disease process and/or clinical study involvement.
• Plan and coordinate initiation of study protocols and operating policies and procedures.
• Assist the principal investigator and research director with day-to-day administrative tasks for studies and projects.
• Plan staffing of studies in coordination with the research director, including recruitment and administration of support staff.
• Plan, implement, and maintain data collection and analysis systems in support of the protocol.
• Monitor progress of research activities; maintain records and prepare reports as required by investigators, administrators, funding agencies, and regulatory bodies.
• Facilitate the assigned clinical trial from start to finish.
• Screen participants for studies independently.
• Summarize and clarify professional guidelines and ethics related to conducting clinical research for study teams.
• Triage phone calls from subjects and address clinical care questions within scope; escalate when needed.
• Adhere to infection control and confidentiality policies.

• Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated

• Adopt the One GI culture of respect, integrity, and accountability to contribute to teamwork and a positive brand image.
• Incorporate a leadership mindset to your role.
• Comply with One GI procedures, policies, and regulations relevant to your role.
• Complete all One GI training requirements (e.g., OSHA, HIPAA, Health Stream, compliance).
• Maintain compliance with all regulatory requirements and guidelines, including OSHA, HIPAA, and…