Req #: 243258 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY Appointing Department Web Address: https://hemonc.uw.edu/ Job Location Detail: This position is located at the Fred Hutchinson Cancer Center in South Lake Union. Posting Date: 02/06/2025 Closing Info: Closes On 02/13/2025 Salary: $5,600 - $6,497 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. **The Division of Hematology & Oncology has an outstanding opportunity for a Lead Data Coordinator to join their team.** **POSITION PURPOSE** The University of Washington, Division of Hematology & Oncology has an excellent position for a Lead Data Coordinator in the Hematologic Malignancies Research Program. The purpose of this position is to support, promote and advance the research objectives of the Hematologic Malignancies Research Program within the Division of Hematology & Oncology at the University of Washington. The Lead Data Coordinator will be responsible for overseeing and facilitating investigator-initiated and pharmaceutical-sponsored clinical trials and working with the various stakeholders, ensuring data quality, team leadership and day-to-day oversight, contributing to protocol and data management, and overall program support. The duties of the Lead Data Coordinator are essential for maintaining the integrity, accuracy, and reliability of clinical trial data. By leading data management efforts, supporting the research program, training staff, and ensuring compliance, the Lead Data Coordinator plays a crucial role in advancing the research objectives of the Hematologic Malignancies Research Program. **POSITION COMPLEXITIES** The complexities of this position stem from the need to manage multiple research projects independently, ensure data integrity and compliance, lead, mentor and train team members in the day-to-day, collaborate with various stakeholders, handle complex clinical data, manage competing deadlines, and contribute to process improvement efforts. These challenges require a high level of expertise, strong organizational and leadership skills, and the ability to work effectively in a dynamic research environment. This position is supervised by and reports to the Senior Data Coordinator of the UW Hematologic Malignancies team. **POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY** The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides significant contributions to research development, implementation and analysis for the Division of Hematology and Oncology. It has a lead role in the analysis of data from research subjects participating in both pharmaceutical-sponsored and investigator-initiated Oncology clinical trials. **DUTIES AND RESPONSIBILITIES** This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with the Clinical Research Program Manager, the Senior Data Coordinator, Research and Data Coordinators, Physicians, other health care personnel (e.g. nurses, mid-levels), research staff at collaborating institutions, pharmaceutical company sponsors and any other groups integral to the successful completion of research projects. Data Management - 55% + Data management of complex clinical research protocols while meeting all sponsor, FDA and University of Washington compliance guidelines. + Oversee the data integrity of 10-15 clinical trials. Understand multiple commercial electronic data capture systems and ensure timely and accurate entry of complex clinical information. + Independently resolve and answer data queries with minimal errors. + Provides oversight of protocol and data for all trials. Develops and implements procedures for data quality control to ensure completeness and accuracy of data. Use problem solving and interpersonal skills to assist with organized process improvement efforts. + Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects. + Independently responsible for completion of sponsor EMR/Data Questionnaires. + Attend and participate in protocol implementation meetings, providing input on data management and quality control processes. + Participate in regular subject chart auditing to provide feedback to the Data Coordinator team (paper and electronic subject charts). + Provide input in design and implementation of research tools for Investigator-Initiated trials using REDCap EDC. + Prioritize effectively multiple competing deadlines from the research team or a sponsor. + Participate in group training sessions with Data Coordinators. + Works with faculty, regulatory, and research coordinators in monitoring visits to resolve data discrepancies. Perform study data updates during teleconferences with sponsors. + Work with various team members and faculty on study close-out activities and archiving of the project. + Generate data reports to support manuscript writing and FDA annual report submission. + Responsible for ClinicalTrial.gov data entry and verification for Investigator-Initiated Trials.Team Leadership, Training and Program Support - 30% + Provide direction, assignments, monitor progress and ensuring that team members meet deadlines and quality standards. Provide coverage when needed. + Participate in the interviewing and hiring of new Data Coordinators. + In the absence of the Senior Data Coordinator, facilitate regular team meetings to discuss ongoing projects, address challenges, and share best practices. + Collaborate with Investigators and study team on the preparation and analysis of study data for publication and grant preparation. + Contributes to clinical informatics projects and presentations with the Senior Data Coordinator for program leadership. + Provide input and participate in the development of data standard operating procedures. Interpret, implement, and verify compliance with applicable federal and institutional SOPs. + Lead initiatives to streamline data collection and reporting processes, ensuring alignment with program goals and priorities.Integrity, Compliance and Oversight - 15% + Interpret and integrate federal, state, sponsor and institutional requirements as they apply to complex clinical and research data integrity. Ensure programmatic compliance with these requirements and guidelines. + Use problem solving and interpersonal skills to assist with organized process improvement efforts.Lead Responsibilities + Oversee and guide team members in the day-to-day operation. Oversee the training curriculum and lead the training of junior Data Coordinators. Mentor junior Data Coordinators, providing ongoing support and feedback to help them develop their skills and knowledge. Works closely with the Clinical Research Program Manager and Senior Data Coordinator with the hiring of new Data Coordinators. **MINIMUM REQUIREMENTS** + Bachelor's Degree in Biology or Health Science. + Minimum 2 years of experience. + Demonstrated understanding of medical terminology. + Strong computer skills and experience with data entry and databases. + Strong attention to detail. + Strong organizational skills and an ability to prioritize multiple projects. + Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues and study sponsor representatives. + Knowledge of Oncology practice and terminology. + Prior working experience at the UWMC and FHCC. + Prior working experience with common eCRF systems (e.g. InForm, Medidata, Medrio etc.). + Competency in Microsoft Office software and Access. + Knowledge of HIPAA regulations. + Knowledge of GCP (Good Clinical Practice). + Knowledge of OnCore CTMS software. + Onboarding and training experience. **CONDITIONS OF EMPLOYMENT** This position is located in a clinical and research environment that is located at the Fred Hutchinson Cancer Center campus. Work hours may exceed 40 hours per week and can be deadline dependent. **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.