Iterative Health
Location
Webster, Texas
The role involves administratively and clinically managing industry-sponsored clinical trials, focusing on patient recruitment, visit coordination, and clinical procedures. The coordinator ensures data integrity, adheres to research SOPs, and maintains communication between sponsors, PIs, and participants.
Candidates must be a Registered Nurse with at least 3 years of clinical research experience and a background or willingness to specialize in GI. Proficiency in phlebotomy and the ability to interpret complex research protocols are highly preferred.
Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Able to manage an increased number of studies and/or more complex studies 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 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 If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate. 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; 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
Registered Nurse Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty Minimum 3 years of clinical research experience 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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