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POSITION PURPOSE
The University of Washington's Division of Medical Oncology's includes faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center, 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 Coordinator. This position will provide regulatory support to the Phase 1 Research Program. At any given time, there will be approximately 50 active clinical research trials and anywhere from 10 to 15 trials in the process of being activated. This position will oversee some 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 affairs requirements mandated by the three Cancer Consortium partner institutions: Seattle Children's Hospital, Fred Hutchinson Cancer Center, and the University of Washington, in addition to the governmental regulatory requirements. This position will oversee the regulatory management of phases I-II industry, investigator-led, and NIH sponsored research studies.

Position Complexities
This position is required to use some independent judgment and should have 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 and FHCRC departments, federal agencies, and industry partners.

This position is supervised by and reports to the Phase I Regulatory Research Manager.

This position will work with moderate supervision performing work assignments and will work closely with the Regulatory Manager, the Research Manager and Coordinators and Fiscal staff. 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 requires some independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance.

The Regulatory Coordinator 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 assess the site. This position is required to coordinate efforts across the Alliance partners including UWMC, FHCC, and SCH departments and staff. The Regulatory Coordinator must be able to work with minimal supervision on multiple research projects without benefit of written policies or procedures. This position works closely with the Regulatory Manager and 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. This position is critical to the success of the Phase 1 Research Program and will be providing oversight of 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. A strong partnership with faculty and staff within and external to the program is required.

Knowledge, Skills and Abilities

Knowledge of Food and Drug Administration, International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to conduction of human clinical trials.

Knowledge of regulatory and administrative requirements of clinical research and translational 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.

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 regulatory compliance for the Division of Medical Oncology. The regulatory coordinator is responsible for overseeing the regulatory affairs of the Phase 1 Research Program's clinical trials. This individual will be responsible for overseeing the management of approximately 20 active clinical trials, in addition to the start up of an additional 10-15 clinical trials. At any one time up to 100 oncology patients will be enrolled on these clinical trials.

DUTIES AND RESPONSIBILITIES

Regulatory Affairs - 90%

This position has the overall responsibility for ensuring that the Phase 1 Research Program research trials meet regulatory requirements and are compliant with federal and institutional policies.

This will necessitate research protocol submissions to various 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.

Oversee regulatory affairs coordination as outlined by protocol objectives.

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.

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 Phase 1 Program clinical trials to ensure regulatory compliance.

Other projects as assigned - 10%

Supervisory Responsibilities.

May direct or guide the work of a student helper.

MINIMUM REQUIREMENTS

Bachelor's Degree in Science or Business.

Minimum 1 year regulatory affairs experience.

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

ADDITIONAL REQUIREMENTS

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.

Ability to work with minimal supervision 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 complete this within 90 days of hire.

DESIRED QUALIFICATIONS

Previous experience working with research trial regulatory affairs.

Knowledge of University of Washington/Fred Hutchinson Cancer Center/Seattle Children's Hospital regulatory processes.

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 sponsors', research program needs, grant deadlines, and faculty needs. These deadlines may require work outside of standard operating hours to meet programmatic needs.

This position is located in a clinical and research environment that is located on the Fred Hutchinson Cancer Research Center campus.

This position is allowed a hybrid in-office/telework option at the discretion of the supervisor.

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 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.