Clinical Research RN Coordinator \" Surgery Division Online Application: Responsibilities Responsible for a variety of specialized clinical research activities, to include; device trials, quantitative clinical research while ensuring that established protocols are implemented, maintains protocol integrity, monitors participants status and safety. Develops, maintains, and updates data collection tools, spreadsheets, and databases for use in gathering and compilation of information specific to each research process. May have responsibility for identifying and recruiting study participants. Assists Investigators as needed in the development of research plans and protocols. Notifies investigators and sponsors of problems or issues, checks on progress and well-being of research subjects and overall direction of the research study. Manages and coordinates complex studies in accordance with established protocols or guidelines Presents the trial concepts and details to the patient and obtains informed consent from patient or guardian. Educates patient regarding his/her rights as a research subject, alternatives of care, and provides teaching specific to protocol drugs, devices, treatments and side effects. requirements prior to patient appointment Prepares, submits, and maintains regulatory documents. Qualifications Massachusetts License as an RN, BS preferred Knowledge and skills necessary for this level are typically attained through 3 or more years of research experience. 3 years of nursing experience preferably in the specialty area of surgery Must demonstrate sound knowledge of clinical research data collection and data report preparation. Solid computer and database skills are essential as well as having experience in the coordination, implementation, and execution of clinical trials. Qualified applicant will hold specialty certification in clinical research through an approved accrediting organization or college/graduate program. Hiring Manager may be willing to consider RN without research certification. Must be committed to obtain Solid computer skills including databases. Strong knowledge of Federal & State Regulations as they relate to research Other Information Full Time 40 hours Monday \" Friday Flexibly in schedule needed to accommodate different active trials or to meet with patients early or late for consent Resume required along with a completed online application Associated topics: coronary, hospice, infusion, maternal, mhb, neonatal, nurse, nurse rn, registered nurse, unit
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