Iterative Health
Location
Hermitage, Tennessee
The CRC II manages industry-sponsored clinical trials, overseeing patient recruitment, study visits, and the collection of clinical data. They are responsible for maintaining study documentation, ensuring protocol compliance, and coordinating communication between sponsors, CROs, and the PI.
Candidates must have at least 3 years of clinical research experience with mandatory experience in IBD. A degree in a clinical or scientific discipline or certification as a Medical Assistant or LPN is preferred.
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, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals 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. 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 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
Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred Minimum 3 years of clinical research experience IBD experience is a must Ability to own issues and problem solve independently Experience in phlebotomy preferred 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 At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health. At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
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