Clinical Research Coordinator II - Nurse

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). 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; 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; 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; 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 consent forms, source documentation, progress notes, 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; Support other site staff with coaching on best practices for clinical trials processes, patient interactions, data integrity, sponsor communication, 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 related to enrollment, screen fails, and protocol adherence; Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations to management; 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; 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

Requirements

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; Strong written and verbal communication skills; 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

Nice to have

Experience in phlebotomy preferred