Req #: 231533

Department: DEPARTMENT OF MEDICINE: HEMATOLOGY AND ONCOLOGY

Posting Date: 03/08/2024

Closing Info: Open Until Filled

Salary: $5,700 - $6,800 per month

Shift: First Shift

Notes: 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. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf )

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.

The University of Washington's Division of Medical Oncology includes 41 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 (Research Coordinator (E S 7)).

This position is one of three who will provide regulatory support to the UW Hematologic Malignancies Research Program. At any given time, there will be up to 80 active clinical research trials/research projects and up to 20 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 (FDA), 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 University of Washington (UW) and Fred Hutchinson Cancer Center (FHCC), in addition to the governmental regulatory requirements.

Position Complexities: This position will oversee the regulatory management. 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 UW, and FHCC departments, federal agencies and industry partners.

This position is supervised by and reports to the Senior Regulatory Affairs Coordinator of the UW Hematologic Malignancies team. This position will work in close alliance with all members of the Program, including the Program's incumbent Regulatory Coordinators.

This position will work independently under administrative direction and will be an expert resource for faculty and research staff on clinical research regulatory policies, procedures, and processes. This position will need to understand research protocols and translate research needs into appropriate regulatory requirements. The regulatory coordinator 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 will assess the site. This position is required to coordinate efforts across the alliance partners including UW and FHCC departments and staff. This position will work with the Clinical Research Program Manager to create and maintain applicable Standard Operating Procedures (SOPs)/guidelines, as well as ensure compliance with the SOPs/guidelines. This position may also perform Quality Assurance checks on regulatory files as needed and implement/maintain relevant training of research staff and collaborators. This position will also implement and maintain standardization of research records in both electronic and hard copy format in order to simplify cross coverage and ensure optimal research compliance and communication.

This position is critical to the success of the UW Hematologic Malignancies 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.

Knowledge, Skills and Abilities:

• Expert knowledge of FDA, 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 and transnational 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 UW Hematologic Malignancies Research Program's clinical trials and research studies. This individual will be responsible for overseeing the regulatory coordination of up to 30 active clinical trials, in addition to the start-up of an additional 1-10 clinical trials. At any one time up to 1000 oncology patients may be enrolled on these clinical trials with additional patients on research studies. DUTIES AND RESPONSIBILITIES Regulatory Affairs- 90%

• Overall responsibility for ensuring the UW Hematologic Malignancies Research Program research trials and projects 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 may work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA, sponsor, 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.

• Maintains and updates all 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 with the Clinical Research Program Manager 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.

• Assist in study start up activities.

• Assist in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial, ongoing submissions and annual reports to the FDA.

• Write 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.

• Assist in the development of protocols for therapeutic clinical trials as well as minimal risk transnational research projects and chart review projects.

• Maintain knowledge and understanding of all active UW Hematologic Malignancies Program clinical trials to ensure regulatory compliance.Other tasks as assigned -10%

• This position must be able to work independently on multiple research projects without the benefit of written policies or procedures. This position requires daily interaction with physicians, research staff at internal and collaborating institutions, pharmaceutical company sponsors, and any other groups integral to the successful completion of research projects. MINIMUM REQUIREMENTS

• Bachelor's Degree -life or social science or related field.

• A minimum of 2 years regulatory affairs or research 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, GCP, and NIH requirements relating to research involving human subjects.

• Experience using electronic data submission software.

• Strong computer skills and competency with Microsoft Office software. Strong attention to detail and ability to multi-task, organize and prioritize multiple projects. Experience in clinical trial processes, implementation of research protocols. Excellent written and verbal communication skills.

• Demonstrated ability to work independently, under supervision, and be a team player. Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.

• Maintain positive vision, sense of humor, and professional demeanor under potentially stressful situations

• 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. DESIRED QUALIFICATIONS

• Knowledge of University of Washington/Fred Hutchinson Cancer Center regulatory processes.

• Experience with WCG IRB. 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 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.

• Work hours frequently exceed 40 hours per week and may be deadline dependent. There may be externally imposed deadlines over which an individual has no control that require a flexible schedule in order to accommodate, such as study sponsor deadlines, 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. 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 your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access 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.

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.