Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Neurology. The position is located at 4488 Forest Park. This position is for the Medical School Campus.
This position is a member of a multi-disciplinary research team and performs duties associated with the coordination and implementation of research clinical trials/projects, data collection, and data generated by DIAN-TU study protocols. This position involves a high level of interaction with the Neuropathology Core as well as a high level of oversight of neuropathology documents for the DIAN-TU trial. The Research Nurse Coordinator II is part of the DIAN-TU Coordinating Center team, evaluating site and HHN training and performance as well as managing the quality of nursing practices and ensuring best practices.
The DIAN-TU is the regulatory sponsor and coordinating center for multi-site, international drug trial(s) for the prevention of Alzheimer’s disease conducted in accordance with ICH/GCP and local regional requirements. The DIAN-TU, including the DIAN-TU Trial(s), is funded through a partnership between Washington University, the Alzheimer’s Association, pharmaceutical companies, the National Institute on Aging, in addition to various other funding sources. Washington University DIAN-TU will serve as the regulatory sponsor and FDA IND holder for the trial(s).
PRIMARY DUTIES AND RESPONSIBILITIES:
Serves as a DIAN-TU Core Liaison.
Supports the full scope of assigned DIAN-TU Core responsibilities.
Participates in educating DIAN-TU staff and sites about the value of assigned DIAN-TU Core.
Contributes to protocol development and ensures timely completion of each in order to ensure an expedited assigned DIAN-TU Core.
Develops informed consent forms, questionnaires, and assists in the development of the application of research techniques.
Provides input to the development of instructional procedures manuals for study progress, data collection and coding.
Development of relevant work instructions and working practices.
Provides phone coverage to answer questions or concerns with sites.
Provides vendor oversight and management to assigned DIAN-TU vendors.
Provides direction and oversees all assigned DIAN-TU vendors associated with a trial to ensure adherence to contract, deliverables, data collection and other trial associated activities.
Manages DIAN-TU vendor budget and timelines to the required standards.
Provides track and provides vendor metrics to DIAN-TU leadership on a regular basis.
Serves as a member of the research team to perform QC reviews of the DIAN-TU trial scale assessments.
Reviews assessment source documentation and recordings to ensure data are obtained according to the established protocol.
Provides feedback for any findings identified in the QC process.
Organization and proper filing of source documents related to clinical assessments.
Reviews federal regulations to ensure compliance (e.g. ICH-GCP).
Creation, review, editing and updating of training and educational materials as well as required manuals for use across multiple drug arms.
Graduate of an accredited nursing program with two years of related nursing or research experience.
Current Missouri RN licensure in accordance with the Compact Act; Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
Clinical research certification; 2 years in an industry clinical trial setting.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of basic computer functions for documentation, communication, and retrieval of information.
Able to work independently and think critically to problem solve.
Willing to learn and apply effective communication strategies to interact with site nurse coordinators, home health nurses, vendors, pharmaceutical partners, and DIAN-TU leadership.
The hiring range for this position is $53,706 - $96,674 annually.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.