The Sr. Research Nurse will function as a senior member of two large coordinating centers performing multisite clinical trials in the areas of Alzheimer's disease and reproductive medicine. Create and implement a medical record abstraction system to obtain pregnancy outcomes and medical history from nationwide community providers. Lead adverse event (and other clinical event) documentation and reporting activities. Develop procedures and systems for data collection and data management for abstracted data and adverse event tracking. Participate in the development of policies and procedures to assure accurate and timely collection of clinical data and reporting of adverse events. Work directly with principal investigators, study analysts, and statisticians to support analytical and monitoring activities.
Specific Duties & Responsibilities
Develop and implement a tracking system for medical record requests from multiple clinical sites
Develop and implement procedures for data abstraction from medical records
Perform medical record abstractions, exercising advanced clinical skills to adjudicate and standardize data collection
Develop systems for monitoring, collating, and cataloging serious adverse events, adverse events, and other clinical events for multiple clinical trials, in accordance with reporting requirements
Develop quality and performance monitoring metrics for above activities; provide reports to executive and steering committees on regular basis
Audit adverse event reporting practices at over 30 clinical trial sites
Provide training and leadership to other study staff
Contribute to clinical trial coordination and management during weekly staff meetings
Create and maintain databases to support record request, record abstraction, and clinical event activities
Interact with other study staff, notably data analysts and statisticians, to support data monitoring and publication activities
Some travel anticipated, performing site visits to monitor and educate sites
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.
Bachelor's degree in nursing or related discipline required.
Two (2) years of experience in a clinical setting or with clinical research
Additional experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience.
Advanced (Master's or Doctoral) degree
4+ years clinical/nursing experience in obstetrics, neonatology, or reproductive medicine
Training in database administration, informatics, or related discipline
Specific experience in multi-site clinical trials
Ability to work independently; strong organizational skills to balance needs of multiple competing projects; ability to integrate clinical and data management/informatics tasks.
Classified Title: Sr. Research Nurse Working Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $70,805 - $80,000; Commensurate with experience Employee group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm; Up to 37.5 hours/week Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 10001101-Epidemiology Personnel area: School of Public Health
The successful candidate(s) for this position will be subject to a pre-employment background check.
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