Clinical Research Nurse Coordinator, Neonatal Services, MMC
Atlantic Health (SP)
Internal Number: 122251234
Atlantic Health System is seeking a full-time Clinical Research Nurse Coordinator for the Neonatal Services at Morristown Medical Center. The Clinical Research Nurse Coordinator will coordinate and performs study specific clinical and regulatory activities across multiple study protocols of different therapeutic areas and phases, in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.
Coordinates and implements the assigned protocols and recruit subjects to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.
Coordinates the development of forms, questionnaires and the application of research techniques; assist in writing procedure manuals. Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in planning.
Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes. Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees, IRBs, amendments, and safety events, process data queries and ensure resolution. Maintain essential staff documents (CV's, licenses, site laboratory certifications) and coordinate Human Protections Training for personnel.
Performs periodic regulatory audits on department studies being coordinated by other coordinators. Develops work plans to address findings.
Works closely with sponsor and study personnel on relevant safety and regulatory issues.
Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across studies and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing tasks and anticipating the effect changes may have on other studies or team members.
High School Diploma or GED required
Graduate of an acredited Nursing Program required
Valid NJ RN License
OCN or CCRC certification required
5 years of relevant Neonatal research experience
Knowledge of Legislative, regulatory and utilization management and quality requirements for health care service delivery
Principles and techniques of project management to ensure that numerous goals, objectives and detailed actions are properly identified, and their status monitored
Principles and practices of managed health care, health care systems, and medical administration.
Clinical criterial application/sources and utilization management processing of prior authorization requests, as well as retrospective and concurrent requests.
Atlantic Health System aims to deliver the highest quality, safety and care combined the best experience for our patients and their families. We are confident that you will find success within Atlantic Health System, which has been named for the 14th year in a row to Fortune's 'Top 100 Best U.S. Companies to Work For' list. We believe you will find that our culture of collaboration and care exemplifies the value we place on our patients, their families and our employees.
Atlantic Health System, Inc. is an equal employment opportunity employer and federal contractor or subcontractor and therefore abides by applicable laws to protect applicants and employees from discrimination in hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral, and other aspects of employment, on the basis of race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, citizenship status, disability, age, genetics, or veteran status.