Job Description

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. Conformance Statements 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. Position Purpose The Clinical Research Assistant (CRA) is a specialized research professional working with and under the direction of the Director, Clinical Principal Investigator (PI) and Clinical Research Coordinators. The primary responsibility of the CRA is to assist the Clinical Research Coordinators with conduct of research studies. The CRA supports and facilitates the daily clinical trial activities and plays a supportive role in the conduct of the study. Responsibilities Assist the Study Team in communication of study requirements to all individuals involved in the study. Assist the Study Team in developing and implementing recruitment strategies in accordance with TDDC RESEARCH and IRB requirements and approvals. Assist the Study Team in screening subjects for eligibility using protocol‑specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. Assist the Study Team in registering participants in the Merge Clinical Trial Management System to ensure billing of study procedures to appropriate funding source. Maintain adequate inventory of study supplies. If handling investigational drugs/devices, follow the sponsor protocol and/or TDDC RESEARCH Policy on Investigational Drug/Device Accountability. Assist the Study Team in completing study documentation and maintaining study files in accordance with sponsor requirements and TDDC RESEARCH policies and procedures, including consent forms, source documentation, narrative notes, case report forms, and investigational material accountability forms. Aide the Study Team in maintaining effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study. Work with the Study Team to manage the day‑to‑day activities of the study including problem solving, communication and protocol management. Collect and report ongoing patient recruitment/enrollment metrics to Director and PI. Arrange secure storage of study documents maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer. Assist the Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations. Cooperate with TDDC RESEARCH compliance and monitoring efforts regarding access, use, and disclosure of PHI and report instances of noncompliance to the appropriate compliance office. Review and update TDDC RESEARCH Study Workflow Chart and enter all patient visit data in e‑CRF and Merge CTMS on a daily basis. Perform other duties as assigned. Qualifications Education: High school diploma or equivalent. Some college preferred. Experience: Minimum two years of experience with a health care organization. Performance Requirements Knowledge of grammar, spelling, and punctuation. Knowledge of purchasing, budgeting, and inventory control. Skill in taking and transcribing dictation and operating office equipment. Skill in answering the phone and responding to questions. Skill in time management, prioritization, and multitasking. Skill in writing and communicating effectively. Ability to work under pressure, communicate and present information. Ability to read, interpret, and apply clinic policies and procedures. Ability to identify problems, recommend solutions, organize and analyze information. Ability to multi‑task, establish priorities, and coordinate work activities. Competently use Microsoft Office, including Word, PowerPoint, Excel, and practice management software. Must be able to lift up to 25 lbs. Must be able to travel and MVR. Equipment Operated: Standard office equipment including computers, fax machines, copiers. Work Environment: Position is in a well‑lighted medical office environment. Occasional evening and weekend work. Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90% of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines. 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. #J-18808-Ljbffr Iterative Health

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