Back to jobs New Clinical Research Coordinator I Providence, RI Apply 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 US and Europe accelerating the path to market for gastrointestinal (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. We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
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
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 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
Participate actively in communication of status and results to management
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
Schedule and prepare for monitor visits
Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates 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’s medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
Perform quality work within deadlines with or without direct supervision
Interact professionally with other employees, customers and suppliers
Work effectively as a team contributor on all assignments
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
Minimum 1-2 years of clinical research experience
Able to execute on research tasks with guidance from more experienced staff, PIs, and management
Strong written and verbal communication skils
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
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