Clinical Research Study Assistant / Regulatory -- Department of Medicine, Division of Hematology & O

Job DescriptionThe Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a temporary Clinical Research Study Assistant to join their regulatory team within the UW Hematologic Malignancies Research Program.This is a temporary, full-time position that is anticipated to last up to 12 months.About this OpportunityReporting to the Senior Research Coordinator of the UW Hematologic Malignancies team, the Clinical Research Study Assistant (RSA) provides a variety of support functions to the regulatory team, including administrative and technical support to the research team to collect and maintain staff credentials. The RSA will also provide administrative support to the Regulatory Coordinators to download and screen safety reports, assist with completion of regulatory documents and help obtain signatures. At any one time, upwards of 50 clinical trials may be active across the disease program, and this position is responsible for organizing and prioritizing numerous concurrent tasks and managing both short-term and long-term multi-step tasks.The RSA works with Division faculty and research staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, implementing multiple research projects to test hypotheses in human subjects. The RSA has daily interactions with research staff, health care personnel (e.g., nurses, patient care coordinators, patient service representatives, medical assistants), pharmaceutical company sponsors, and other groups integral to the successful completion of the research project.The Research Study Assistant works on-site at the Fred Hutch Cancer Center (FHCC), and project work visits may be required during the work shift at local affiliate locations. The position may be eligible to be considered for a hybrid telework work schedule based on business needs, working remotely up to three days per week, once fully trained and demonstrating telework readiness.Key ResponsibilitiesSafety Data Coordination, Abstraction and Analysis (30%):Work independently to abstract safety data from multiple sources (sponsor portals and reports, etc.) for research analysis by Regulatory Coordinators and Principal Investigators.Make independent judgments about the relevance of the safety data to the research for complicated oncology research studies.Principally responsible for monitoring and tracking upcoming pharmaceutical sponsor and government audits and maintaining research credentials.Understand research study flow and work with research regulatory team members to perform the required research support tasks at appropriate study time points.Administrative (40%):Obtain faculty signatures both in-person and electronically.Assist administrative staff with archiving of older documents.Regulatory records management.Credential Coordination (30%):Independently maintain and track current and former staff credentials and trainings.Obtain laboratory credentials from external facilities.Perform other related tasks as assigned.Required QualificationsTo be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.Minimum QualificationsApplicants who do not meet these minimum qualifications WILL NOT be forwarded to the Hiring Manager.Two years of college-level course work in a relevant academic area AND one year of appropriate experience.Additional QualificationsDemonstrated understanding of medical terminologyStrong computer skills and experience with data entry and databasesStrong attention to detail and ability to organize workAbility to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representativesDemonstrated ability to work independently and to carry out complex tasksPreferred QualificationsBachelor’s degree in science-related fieldKnowledge of oncology practice and terminologyPrior working experience at the UWMC, FHCC, and/or SCCAPrior experience in basic processing laboratory samplesCompetency in Microsoft Office softwareKnowledge of HIPAA regulationsWorking ConditionsThis position is in a clinical and research setting that is located on the Fred Hutch Cancer Center campus.Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.There may be externally imposed deadlines over which an individual has no control and that require a flexible schedule in order to accommodate, such as study sponsor deadlines, research program needs, grant deadlines, and faculty needs. Work hours may exceed 40 hours per week and can be deadline dependent.Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete this training within 30 days of hire.About the TeamThe University of Washington's Division of Hematology & Oncology includes 200+ staff members and 450+ faculty members located at the UW Medical Center (UWMC), the Fred Hutch Cancer Center (FHCC), and the VA Puget Sound Health Care System. As the premier hematology/oncology program in the Pacific Northwest, we balance the twin aims of innovative, life-saving research and knowledge-driven, patient-focused cancer care. Over the past 40 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.#UWDeptMedicineJobsCompensation, Benefits and Position DetailsPay Range Minimum:$45,144.00 annualPay Range Maximum:$50,736.00 annualOther Compensation:-Benefits:For information about benefits for this position, visit Shift (United States of America)Temporary or Regular?This is a temporary positionFTE (Full-Time Equivalent):100.00%Union/Bargaining Unit:SEIU Local 925 NonsupervisoryAbout the UWWorking 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 CommitmentThe 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 View phone number on click.appcast.io or View email address on click.appcast.io .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 . #J-18808-Ljbffr University of Washington