Req #: 240146 Department: Department of Medicine: Pulmonary, Critical Care a Posting Date: 10/17/2024 Closing Info: Open Until Filled Salary: $7,500 - $9,500 per month 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 purpose of this position is to lead, conduct and manage translational and clinical research studies that focus on a highly complex clinical sub-specialty patient population (including vulnerable populations) involving adults with sleep disorders and cardiopulmonary disease. The University of Washington (UW) Division of Pulmonary, Critical Care and Sleep Medicine is nationally and internationally recognized for its clinical and translational research programs. The Research Coordinator will work with Principal Investigators, collaborating research staff, medical center staff and research teams comprised of scientists and post-doctoral trainees. Investigators in this program participate in multi-site industry and federally and non-federally funded research. The Lead Research Coordinator is responsible for leading 3-5 research projects concurrently and for training and advising staff within the UW Medicine system clinical settings and at collaborating enrollment sites. **Position Complexities:** This position requires experience in clinical research operations and compliance. The research coordinator will be working with adults with sleep disorders and cardiopulmonary disease patient population requiring coordination with providers from multiple other medicine sub-specialties. The research coordinator must have a working knowledge of the complexities of each study protocol and be able to assess and abstract clinical data from the electronic health record to identify eligible study candidates. The research coordinator must demonstrate a high level of expertise to support multiple, complex studies while adhering to guidelines and policies of the University of Washington, UW Medicine, and funding sponsors including NIH, private foundations, and private industry sponsors. **Position Dimensions and Impact to the University:** This position provides expertise to Principal Investigators, co-investigators and other research staff which is crucial to the UW maintaining its reputation as a research leader. **DUTIES AND RESPONSIBILITIES** Clinical Research and Project Management/Operations (55%) + This position is responsible for leading the implementation and ongoing operational management of clinical research trials and related data collection and analysis projects including the acquisition of biological specimens for retention and secondary analysis. The research coordinator will contribute to protocol development and revisions to address new clinical research questions. The research coordinator will be responsible for identifying protocol implementation barriers and working with investigators to develop responsive modifications that resolve and remove these barriers. + Working in the outpatient clinic setting, the research coordinator leads and oversees the efforts of team members to screen, recruit, and consent subjects for research participation. The research coordinator provides patient participants with orientation and education on the research tools employed to meet the goals of the funded award. In addition to collecting biospecimens, the research coordinator will administer clinical survey instruments, and gather clinical data points from the electronic health record system (EPIC) or through clinical procedures administered in a clinical setting. + The Research Coordinator will be responsible for conducting a wide variety of highly technical clinical tests to assess suitability of participation and to confirm inclusion and exclusion criteria considerations have been met. Procedures vary based on study protocol and include initiating and titrating CPAP (continuous positive airway pressure) therapy and close monitoring and adjusting setting and patient compliance pulmonary function testing (including specialized exercise testing to measure lung capacity), administering spirometry, conducting 6-minute walk tests, administering ECGs (electrocardiogram tests), data collection and acquisition from implanted cardiac devices, and obtaining blood and urine samples. + The research coordinator will acquire biorepository data and specimen collection and ensure compliance and adherence with protocol requirements. This position is responsible for subject identification and recruitment, protocol implementation, data acquisition and validation. The research coordinator ensures accurate tracking of milestone activities, submission of data to sponsor portals, resolution of sponsor queries that may delay study payments and timely payment of study subject stipends and/or travel reimbursements. The research coordinator investigates and documents study costs for grant proposals and post-award expenditure management and provides milestone data necessary to ensure invoices are regularly submitted to sponsors. + The research coordinator works with investigators on cohort development and retention. Retention efforts require ongoing subject contact via e-mail, phone, and mail at standardized intervals to collect longitudinal data. + The Research Coordinator develops research designs, data collection methods and strategies for data management including: + Research protocols and procedures necessary to test the hypotheses of the research studies. + Forms, questionnaires, and clinic procedures for collecting and summarizing observations and data + Research designs, data collection methods/tools and strategies for data management. + The Research Coordinator authors technically detailed scientific documentation and study materials appropriate for a general audience and clinical/technical audience.Regulatory Compliance (30%) + This position has the overall responsibility for ensuring that the Research Program clinical trials meet regulatory requirements and are compliant with federal and institutional policies. This will necessitate research protocol submissions to various institutional and external IRBs, ongoing tracking of annual IRB renewals, submission of annual reviews, modifications to existing protocols, SAEs and protocol deviations to the appropriate IRB. This position must be able to work with minimal supervision on multiple research projects. This position works closely with the other RCs across Pulmonary, Critical Care, and Sleep Medicine research and requires frequent interactions with physicians/PIs, research staff at collaborating institutions, pharmaceutical company sponsors and any other groups integral to the successful completion of research projects. + Responsible for timely completion of all regulatory materials required to initiate clinical research projects at the UW. Regulatory compliance obligations include but are not limited to IRB submissions via the Zipline system and direct response to Human Subjects Office, study approval, enrollment and activation in multiple UW systems including RedCap, a clinical survey database, and OnCore, a clinical trial management system that is designed to integrate with the Workday Finance system to manage sponsor invoicing and payments. + The sleep research group utilizes specialized clinical space within the Translational Research Unit and the UWMC Lung Testing Center. Each study requesting use of these facilities must complete corresponding application and approval processes for use of clinical spaces to conduct research. + The Research Coordinator is also responsible for registering all clinical trials with the UW Medicine Clinical Trials Office and assessing each milestone activity for billing determinations (whether the expenses should be charged to the sponsored project or is the responsibility of the patient). The Research Coordinator is responsible for reviewing all study billings for accuracy and addressing any necessary corrections and for participating in periodic internal audits to test financial controls + The Research Coordinator acquires and validates clinical data and submits sponsor reporting on the gender, race and ethnicity of participants, reports clinical data points to sponsor portals and assists the Principal Investigators with meeting NIH Dissemination obligations on the ClinicalTrials.gov reporting platform. + The Research Coordinator works with research administration staff to ensure timely submission of documents to the Office of Sponsored Programs. + The Research Coordinator develops study manuals, documents clinical protocols and training materials for use by study participants and collaborating investigators.15% Training, education, and oversight + The research coordinator is responsible for training and orienting new team members (staff and trainees) to protocol implementation, compliance obligations and conduct of clinical procedures noted above (e.g., pulmonary function tests, spirometry, etc). + Train and advise staff within the UW Medicine system clinical settings and at collaborating enrollment sites. + The research coordinator ensures that all new team members complete required trainings to obtain access to multiple systems used to record study visits, review and record clinical data, screen study subjects, and ensure the sponsored studies are appropriately charged. + The Research Coordinator reviews data acquired by other team members for accuracy and to address any validation concerns while ensuring timely entry of data to meet study endpoints.Lead Responsibilities:Lead coordinator responsibilities include but are not limited to training individuals on the use of multiple UW systems (e.g., RedCap, Oncore, Zipline) required for the conduct of clinical research. Additionally, processes for obtaining approval to use medical center specialized clinical research space (e.g., Translational Research Unit, UWMC Lung Testing Center) and completing processes within the Clinical Trial office for any research project utilizing clinical resources. The lead coordinator is responsible for assigning work and training other research coordinators in the conduct of clinical procedures (e.g., lung function testing, spirometry, etc) and for providing quality control checks to their work. **MINIMUM REQUIREMENTS** + Bachelor's degree in a health sciences or clinical health field. (Equivalent experience may substitute for the degree requirement) + 3 years minimum work experience.Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. **DESIRED QUALIFICATIONS** + Clinical research operations experience including project management and long-range planning. + The individual must have excellent verbal, written and interpersonal communication skills. + Proficiency in Microsoft Office software required. + The individual must have demonstrated problem-solving skills, strong detail orientation and ability to adeptly manage multiple priorities and timelines. + Due to the multi-disciplinary nature of the clinical/translational research interaction, this position must have the ability to work with various individual working styles and organizational systems is necessary. **DESIRED QUALIFICATIONS** + Proficiency in RedCAP data entry required and RedCAP database creation. + Familiarity with UW research policies and guidelines. + Phlebotomy experience.Working Environmental Conditions:The research coordinator works in a clinical setting and coordinates specimen management with laboratory staff. **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 access 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.\#UWDeptMedicineJobs 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.