• Responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. • Conduct monitoring activities using different methods, (e.g., both on site and remote). • Collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready.

Job Description The Department of Medicine, Division of Nephrology, has an outstanding opportunity for a full-time, temporary Research Consultant 2 position. The candidate will work with the Shankland Lab group to analyze high-throughput data sets related to the kidney in the settings of pre-clinical models of disease and aging. Specifically, the lab utilizes transcriptional profiling approaches to understand the molecular mechanisms of disease and also of aging, their progression, and response to treatments. We used publicly available human data to translate our experimental data. The lab is well funded by the NIH. This position includes ownership of projects, support of other researchers, and working with our collaborators. The candidate will have access to team of bioinformaticians providing computational analysis and support at UW Medicine’s South Lake Union campus. This position has a high degree of autonomy and requires personal initiative, discretion, and flexibility to perform complex analytic processes related to data analysis. This employee must possess knowledge and understanding of the complexities of assessment, evaluation, and data as well as a high degree of knowledge of statistical analysis software and scripting languages (e.g. R). RESPONSIBILITIES Research Data Processing: - Process raw sequence data including quality control, alignment, and normalization with command line tools (e.g. FastQC, STAR, samtools) - Analyze high-dimensional RNA-seq, genetic, and/or single cell sequencing data including statistical modeling and visualization using existing R packages (e.g. limma, lme4, Seurat) - Perform and document workflows using reproducible programming techniques (e.g. Rmarkdown, Git) - Collaborate with other bioinformaticians on reproducible workflows, shared methods, and community code projects (e.g. GitHub) - Contribute to experimental design with downstream analyses in mind - Work directly with bench scientists and researchers to develop scripts to improve data organization, management, and analysis to best serve the needs of evolving projects - Analyze publicly available databases relevant to the kidney such as KPMP Research Data Analysis: Participate in data analysis and dissemination of results to include: - Co-author peer-reviewed publications - Present at scientific conferences where appropriate - Create text, tables, figures, and charts for presentations and publications, and for the PI’s grant submissions - Communicate computational methods and results to non-computational researchers in the lab MINIMUM REQUIREMENTS - Bachelor’s degree in a related field and two years of experience involving data analysis, statistical software, and scripting languages. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration. DESIRED REQUIREMENTS - Masters in bioinformatics, computational biology, or other area with relevant biology and data science experience - Fluency in R (R scripts and R Markdown) - Experience with packages such as Seurat, bpCells, ggplot2, tidyverse, dplyr, and others for visualization - Fluency in Python using Visual Studio Code and Jupyter Notebook, mainly with libraries like pandas, numpy, scanpy, Squidpy, matplotlib, and others for single-cell and spatial analysis - Interest in kidney research - Exposure to machine learning and deep learning concepts - Demonstrated ability to participate productively in interdisciplinary research teams - Self-motivation and flexibility - Strong organization and communication skills #UWDeptMedicineJobs Compensation, Benefits and Position Details Pay Range Minimum: $65,352.00 annualPay Range Maximum: $120,372.00 annualOther Compensation: -Benefits: For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-temporary-per-diem-and-less-than-half-time/Shift: First Shift (United States of America)Temporary or Regular? This is a temporary positionFTE (Full-Time Equivalent): 100.00%Union/Bargaining Unit: Not Applicable About the UW Working at the University of Washington provides a unique opportunity to change lives – on our campuses, in our state and around the world. UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty. Our Commitment The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.

• Research and document prior authorization and benefit verification requirements across diverse payors (commercial plans, state Medicaid programs, etc.) • Investigate payor-specific submission processes: required documents, portals, fax numbers, CPT code requirements, and policy updates • Stay informed on payor policy changes, especially those affecting authorization processes and benefit structures • Navigate payor websites, newsletters, and representative communications to gather accurate, up-to-date information • Validate information from multiple sources and determine credibility of payor guidance • Work independently to solve ambiguous problems where established processes don't yet exist • Communicate findings clearly to cross-functional stakeholders and adapt quickly to feedback • Handle tight deadlines and shifting priorities in a fast-paced startup environment

CRA I -Sponsor Dedicated - Oncology(Central Region) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture Verifies site compliance with electronic data capture requirements - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. - May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out Knowledge of local requirements for real world late phase study designs Chart Abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.