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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 in the Department of Medicine has an outstanding opportunity for a full-time Regulatory Affairs Coordinator.
This position is required to use independent judgment, leadership, and expert 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, SCCA, and FHCRC departments, federal agencies, and industry partners.
This position is supervised by and reports to the Research Manager of the Breast Cancer Research Program (BCRP).
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. This position will need to understand the research protocols and translate research needs into appropriate regulatory requirements. It will integrate information from multiple sources and use 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 the sponsor assesses 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 Breast Cancer Research Program and will be instrumental in providing oversight of all research regulatory compliance. This position will not only impact the BCRP 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.
Knowledge, Skills and Abilities:
Expert knowledge of Food and Drug Administration, International Conference on Harmonization, Code of Federal Regulations, and Good Clinical Practice policies and guidelines as they relate to conduction of human clinical trials.
Expert knowledge of regulatory and administrative requirements of clinical research projects.
Thorough 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.
Position Dimensions and Impact to the University:
The mission of Medical Oncology currently has an outstanding opportunity for a Regulatory Affairs Coordinator. This individual will manage and administer the regulatory affairs of the Breast Cancer Research Program (BCRP). At any given time, the BCRP has over 30 active clinical research trials and over 15 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 the BCRP on 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 BCRP regulatory management of phases I-IV industry, investigator and NIH initiated clinical trials.
Duties & Responsibilities:
This position is critical to the success of the UW Breast Cancer 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.
Overall responsibility for ensuring the Breast Cancer Research 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.
Participate in reviewing and assessing incoming research projects and assist investigators and Research Administrator with feasibility analysis from a regulatory perspective.
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 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 for investigator-initiated clinical trials. Coordinate submissions with the Food and Drug Administration.
Maintain knowledge and understanding of all active BCRP clinical trials to ensure regulatory compliance.
Coordinate and submit on-going regulatory documents to institutional and external IRBs.
Ongoing tracking of annual IRB renewals, submission of annual reviews, modifications to existing protocols, SAEs and protocol deviations to the appropriate IRB.
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, investigator and research staff CVs, medical licensures, and related forms per sponsor or federal requirements.
Maintains and audits study-specific regulatory files and location-profile filing system per FDA guidelines.
Monitor, distribute and maintain safety documents including Investigational Drug Brochures IND safety reports and Serious Adverse Events (SAE) reports.
Queries and updates BCRP ACCESS database containing all Regulatory information and tracking capabilities.
Use sound judgment skills to independently assess prioritization of all regulatory affairs to include protocol submissions, clinical trial regulatory maintenance, regulatory document collection, submission of protocol violations, contacting of Sponsors and IRBs to ensure timely IRB approvals in addition to other tasks.
Preparing all research protocol required regulatory documents for submission to various IRBs (WIRB, UW, Cancer Consortium)
Writing consent forms for research protocols for IRB submissions
Corresponding with IRBs and institutional departments in regard to protocol initiation within the Consortium
Maintenance of all regulatory files to ensure regulatory compliance per FDA requirements, i.e., annual IRB renewals, protocol modifications, consent form changes and updates, SAE submissions, etc.
Maintain electronic files of all regulatory documents in an electronic database
Maintain all paper regulatory documents for audit ready purposes per FDA guidelines
Other Projects as assigned
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.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in health-related field plus a minimum of 2 years 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 needs, research 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 can be 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.