Req #: 230313

　　Department: DEPARTMENT OF EMERGENCY MEDICINE

　　Posting Date: 01/19/2024

　　Closing Info: Open Until Filled

　　Salary: $6,263 - $13,264 per month

　　Limited Recruitment: Open to UW Employees only

　　Shift: First Shift

　　Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf )

　　As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.

　　UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.

　　POSITION PURPOSE

　　The Clinical Research Manager (CRM) is responsible for independently implementing multiple clinical research projects, which currently includes projects across a variety of emergency medicine clinical topics including trauma, sepsis, resuscitation science, health services and substance use. This position is required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, FDA, NIH, and the study sponsors. The CRM develops and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Department of Emergency Medicine. The CRM works with the research team to collect and abstract clinical data from medical records and research charts, works closely with physicians, nursing, and research staff in providing administrative and technical support for research projects, and follows complex instructions for processing laboratory samples (including blood, urine, and tissue samples) for tracking, storage, or shipping. In addition, the CRM participates in determining feasibility for upcoming clinical trials. In this capacity, the CRM represents the Department, providing potential sponsors and other departments with the necessary information to determine site selection, staffing and funding. The CRM works independently on multiple research projects without benefit of written policies or procedures. The CRM has daily interaction with physicians, other health care personnel (e.g. nurses, patient care coordinators, patient service representatives, medical assistants), industry sponsors and any other groups integral to the successful completion of the research project.

　　DUTIES AND RESPONSIBILITIES Staff Management - 30%

　　The CRM is the primary supervisor expected to manage a research study team of new and experienced research assistants and coordinators. Assist new Principal Investigators with study design, implementation, budgets and staff resource allocation. Provide training and managerial support to all Clinical research staff in the Department of Emergency Medicine. Mentor lead research coordinators and train on higher level tasks, as appropriate. Collaborate extensively with other departments to ensure 24/7 research staff coverage and manage shared resources. Responsible for hiring of research staff in the department while working closely with department HR.Protocol Management and Regulatory Compliance – 20%

　　Design, create, complete, and revise research instruments (case and control consent forms) as necessary to ensure quality data that correlates with research objectives.

　　Understand and ensure compliance with all IRB Protocols within the Department (currently over 70 active IRB Approved Protocols). Support all research faculty and trainees in the Department with IRB creation, submission and compliance. This includes annual renewals, new protocols, modifications, and study closeout with assistance from regulatory coordinator.Research Patient Management - 10%

　　Create and manage patient study records, including management of study binders, source documentation, and incoming paperwork. This includes generation, completion, and review of patient specific documentation.

　　Manage complex studies including: screening support, ordering tests & procedures to facilitate protocol adherence, billing compliance, and ensure accurate and reliable data collection.

　　Participate in consenting of patients with providers and independently depending on protocol requirements. Educate patients about clinical study requirements and visit schedule. Conduct telephone and face to face interviews with patients to collect research data per protocol.

　　Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary. Communicate with investigators and staff when financial milestones have been met.Data Coordination, Abstraction and Analysis - 10%

　　Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data-capture systems (both electronic and paper-based). Resolve and answer data queries with minimal errors.

　　Make independent judgments about the relevance of the clinical data to the research for complicated research subjects. Principally responsible for maintaining computer spreadsheets and databases for research studies.

　　Understand research study flow; work with ED staff support services and research team members to set-up clinical research in the Emergency Department. With study team, draft scheduling request orders to meet study protocol needs. Independently develop study-specific or program data acquisition forms.

　　Work professionally with sponsor representatives to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions. Work with Principal Investigator to consent patients for open research studies.Research Tracking and Coordination in the Emergency Department - 10%

　　Independently maintain and track current research studies and targeted enrollment in the ED. Support the Department's EMIRC (Emergency Medicine Interdisciplinary Research Committee), which aims to work with all investigators that are doing research with patients and/or providers within the ED space at UWMC and HMC. Responsible for annual DEM Research Showcase program in collaboration with DEM Residency, overseeing the timely collection of abstracts, coordination of entire event and implementing a scoring algorithm, for awards.Clinical Trial Management System (CTMS) Data Entry - 15%

　　Train Research Study Coordinators on entering completed patient visits, protocol deviations and additional data points into CTMS system. Collaborate with members of research team to ensure data entry is up to date and accurately reflects activities relating to research. Responsible for initiation of all new studies in CTMS system.Research Billing - 5%

　　Assist Grant and Contracts Manager in insuring proper billing of research charges.

　　Additional duties as deemed qualified. MINIMUM REQUIREMENTS

　　BA/BS in a science-related field and four to five years of experience in clinical research.

　　Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS

　　Demonstrated understanding of medical terminology.

　　Strong computer skills and experience with data entry and databases (REDCap).

　　Strong attention to detail and ability to organize work.

　　Previous supervisory experience of at least 1 year.

　　Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives.

　　Knowledge of Emergency Medicine and terminology.

　　Prior experience in basic processing laboratory samples and prior experience with clinical research: recruitment of patients and clinical trials. Application Process: The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

　　University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.