This is an advanced nursing position that involves clinical patient contact, research study coordination, and study data management. The role requires the ability to organize complex components of clinical trials, including test ordering, procedure scheduling, and insurance pre-authorization for participants. Clinical skills may include patient assessment for adverse events and assistance with or completion of study-related procedures such as injections, phlebotomy, or infusions, within the applicable state scope of practice. The position demands a desire and ability to strictly adhere to all levels of institutional, state, and federal regulations and established research protocols. Collaboration with physician investigators is essential to ensure safe and compliant investigational treatment or intervention and follow-up. Responsibilities include attending investigator meetings, coordinating pre-study site visits, monitoring enrollment goals, modifying recruitment plans as needed, and ensuring the completion of all screening, eligibility, and enrollment procedures. The role also involves working with pharmacy to dispense study articles, providing subject education, clarifying questions with the investigator and sponsor, reviewing inclusion/exclusion criteria, and discussing study protocols and informed consent forms with potential subjects. Scheduling follow-up visits, ensuring appropriate specimen collection, batching, and shipping, and documenting all study-related procedures, processes, and events are key duties. The role requires documenting protocol deviations and exemptions, recording accurate and timely data, maintaining accurate source documentation, and abstracting data from medical records. Effective communication with subjects, the research team, the Institutional Review Board (IRB), and sponsor representatives is crucial. Occasional local travel between sites and student supervision may be required.
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Job Type
Full-time
Career Level
Senior
Education Level
Associate degree