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The University of Washington's Division of Medical Oncology includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 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.
The Division of Medical Oncology has an outstanding opportunity for a full-time Regulatory Affairs Coordinator. This position will provide regulatory support for the Sarcoma Research Program. At any given time, there will be approximately 40 active clinical research trials and anywhere from 5-10 trials in the process of being activated. This position will oversee all aspects of submission and continuous reporting to the relevant regulatory agencies, including the Institutional Review Board, the Food and Drug Administration, the Institutional Biosafety Committee, the institutional Radiation Safety Committee, and the pharmaceutical sponsor, funding foundation, or governmental agency. In addition, this position will have knowledge of and represent these research programs in all regulatory affair requirements mandated by the three Cancer Consortium partner institutions: the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington, in addition to the governmental regulatory requirements. This position will oversee the regulatory management of phases I-IV industry, investigator-led, and NIH sponsored research studies.
The purpose of this position is to manage and administer the regulatory affairs of the Sarcoma Program. This position will work closely with the Sarcoma Program leadership, preparing documents for IRB submission of clinical research protocols. This position will coordinate the collection and submission of regulatory and research protocol required documents to Sponsors, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center and the University of Washington. Ongoing regulatory management of various phases of industry, investigator and NIH initiated clinical trials will be part of this position.
The Division of Oncology is physically located in the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position requires operational knowledge of the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance. This position is required to use independent judgment, leadership and knowledge of the academic clinical trial healthcare regulatory operations to effectively facilitate the work flow and promote a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, SCCA departments, and the FHCRC departments, federal agencies and industry partners.
This position will work with minimal supervision in performing work assignments and will work closely with program management, the Research Coordinators, and Data Manager in making judgments and decisions within guidelines of UW and sponsor agency policies.
This position is constantly required to integrate information from multiple sources to ensure that all research protocols are correctly navigated through the institutional start up procedures, and submitted within the IRB, Cancer Consortium and Sponsor required guidelines.
This position requires independent decision making on all aspects of the research study start up process as well as ongoing regulatory affairs work. This position is required to coordinate efforts across the Alliance partners including UWMC, FHCRC, SCCA, and Harborview departments and staff.
This position is key to the success of the Sarcoma Program. It will require a strong partnership with faculty and staff within and external to the program.
Knowledge, Skills and Abilities:
Knowledge of administrative requirements of clinical research projects.
Understanding of theoretical objectives of clinical research projects.
Strong organization, communication, and interpersonal skills to work effectively with study sponsors, investigators, and research personnel involved in research projects.
Comprehensive knowledge of FDA and ICH guidelines, Standard Operating Procedures (SOP), and Good Clinical Practice (GCP).
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 regulatory compliance for the Division of Oncology. It is responsible for overseeing the regulatory affairs of the Sarcoma Oncology clinical trials, the majority of which provide significant financial support for the Division of Oncology.
This position is supervised by and reports to the Regulatory Affairs Manager of the Sarcoma Research Program.
This position will work independently under administrative direction and will be the expert resource for faculty and research staff on clinical research regulatory policies, procedures, and processes. The successful candidate will need to understand the research protocols and translate research needs into appropriate regulatory requirements. This will require integration of information from multiple sources and use of specialized regulatory knowledge of the governing clinical research policies, to ensure all clinical trials are compliant with applicable federal and institutional regulations.
This position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines, which is a key metric by which sponsors assess the site. This position is required to coordinate efforts across the Alliance partners including UWMC, FHCRC, and SCCA departments and staff.
This position will work to create and maintain program Standard Operating Procedures (SOPs), as well as ensure program compliance with the SOPs. This position may also perform Quality Assurance checks on regulatory files as needed.
This position is critical to the success of the Sarcoma Research Program and will be instrumental in providing oversight of all research regulatory compliance. This position will not only impact these research programs but also the Division of Medical Oncology ensuring compliance with all regulatory requirements. It will require a strong partnership with faculty and staff within and external to the program.
This position has the responsibility for ensuring that the Sarcoma Program research trials meet regulatory requirements and are compliant with federal and institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution, and patient safety. This position works with minimal supervision and uses sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA, etc.).
Oversee, coordinate, and implement all 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.
Write/edit clinical research trial consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate “Elements of Informed Consent”. Translate complicated research protocol requirements into language easily understandable by research participants.
Assist faculty in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial and ongoing submissions, and annual reports to the Food and Drug Administration.
Maintains and update all required regulatory documents (FDA Form 1572 and/or 1571, Protocol Signature Page, Investigator Brochure, Financial Disclosure, laboratory accreditations, laboratory reference ranges, investigators’ and research staffs’ CVs, medical licensures, and related forms per sponsor or federal requirements)
Assist in the development of protocols for therapeutic clinic trials as well as minimal risk translational research projects and chart reviews.
Maintain knowledge and understanding of all active Genitourinary Medical Oncology (GUMO) clinical trials to ensure regulatory compliance.
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 physicians, research staff at collaborating institutions, pharmaceutical company sponsors and any other groups integral to the successful completion of research projects.
Collaborate with internal and external partners. Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.
May direct or guide the work of a student helper.
Other responsibilities as assigned and deemed qualified
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.
Bachelor's Degree in Science or Health-related field plus a minimum of 2 years of regulatory affairs experience
Knowledge of IRB submission procedures, FDA and NIH requirements relating to research involving human subjects. Experience using electronic data submission software.
Sound knowledge of Microsoft Office, Word, Excel. Experience in clinical trial processes, implementation of research protocols and excellent written and verbal communication skills, and attention to detail.
Able to work independently and be a team player; to maintain positive vision, sense of humor, and flexibility; to multi-task and as priorities change, maintaining a professional demeanor at all times.
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to do so..
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance regulatory processes.
CONDITIONS OF EMPLOYMENT
Sitting at desk for majority of hours worked; working on a computer and on the telephone in a cubicle in a public area with little privacy. Ability to multi-task and be flexible is crucial as priorities change throughout each day. May have to respond to multiple requests for information (email, voicemail, fax, verbal), determining priorities.
There may be externally imposed deadlines over which individual has no control that require a flexible schedule in order to accommodate, such as study sponsor deadline, researh program needs, grant deadlines, and faculty needs. This position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. Work hours frequently exceed 40 hours per week and are often deadline dependent.
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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.