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. All of which has allowed the UW to be nationally recognized as a "Great College to Work For" for five consecutive years. The Division of Hematology in the Department of Medicine has an outstanding opportunity for a full-time Research Coorindator.This position must be able to work independently under administrative direction on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.This position must be able to work independently under administrative direction on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.Protocol implementation Independently develop and implement research project procedures and tools that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA). Communicate research requirements effectively with all providers involved in patient careDesign, develop, document and maintain policies and procedures for protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.Ensure protocol compliance by managing patient appointments and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data. Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient's clinical providers. Initiate and maintain communication with outside physicians who collaborate in the care of patients on UWMC/SCCA oncology clinical trials.Manage clinical trial start-up processes Establish and maintain methods to initiate study start-up budget planning.Use knowledge of clinical research, medical terminology, and clinical processes to translate complex oncology protocol requirements into clinical trial budgets and facilitate submissions to relevant compliance offices.Working with the Research Managers and faculty, establish methods to translate study start-up pricing and budget efforts into study tracking tools, to streamline the invoicing of sponsors based on patient accrual and visits.Forecast, track and report study start-up timelines.Develop and track study start-up pieces and report progress to Research Managers, faculty, and study team members.Produce monthly and quarterly study start-up metric reports using established formats.Regulatory maintenance Coordinate and implement regulatory submissions to internal and external governing bodies. These include but are not limited to the Institutional Review Board, the Institutional Biosafety Committee, the Institutional Radiation Safety Committee, and the Scientific Review Committee. This includes new study applications, annual reviews, modifications to existing studies, serious adverse events, and protocol deviations.Ability to update required regulatory documents (FDA Form 1572 and/or 1571, protocol signature page, Investigator's Brochure, financial disclosures, laboratory accreditation, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and related forms per sponsor or federal requirements). Work on the development of SOPs/guidelines and identify/maintain training requirements of the research team and collaborators. Implement/maintain standardization and organization of research records and communication in electronic and hard copy format to ensure optimal research compliance and communication within and outside of the research team.Collaborate with the Research Manager IND, IDE, and exemption submissionsWrite clinical research trial consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent. Translate complicated research protocol requirements into language easily understandable by research participants and laypersons.Maintain knowledge and understanding of all active clinical trials to ensure regulatory complianceLead Responsibilities:Manage complex clinical research protocols successfully and meet all regulatory and compliance guidelines.Develop key research collaborations with internal and external partners.Disease program expert on clinical trial operation, regulatory, and start up processesAs a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.REQUIREMENTS: BA in Biology or health-related field, three years experience in clinical research project coordination, and knowledge of FDA and NIH requirements relating to research involving human subjects, experience in clinical trial development, implementation and analysis, excellent written and verbal communication skills, experience in solid tumor oncology and hematology. Being able to work in a fast-pace clinical research program.Applicants selected for this position who have note already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire.Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.DESIREDExperience developing clinical trial budgetsExperience in oncology clinical researchExperience in an academic environmentCONDITIONS OF EMPLOYMENT Application Process:The application process for UW positions 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 Workforce 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 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.
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