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Job Details

REGULATORY COORDINATOR

Salary
Salary is commensurate with ex

Location
Seattle, WA

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Shift:
First Shift
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. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for four consecutive years.

The University of Washington's Division of Medical Oncology includes 41 faculty 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, and members located at the UW Medical Center, the Fred Hutchinson Cancer Research tibody-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 for the Genitourinary Medical Oncology (GUMO) Research Program. At any given time, there will be approximately 30 active clinical research trials and anywhere from 15 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,

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 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.

A key mission of the GUMO CTC is the conduct of basic, clinical, and translational Genitourinary Oncology research. At any given time, multiple clinical treatment trials are actively accruing at the Seattle Cancer Care Alliance (SCCA) and the University of Washington Medical Center (UWMC).
Under the direction of the GUMO CTC Director and Research Manager, this individual provides professional level support for clinical research studies involving human subjects.

This position is supervised by and reports to the Research Manager of the Genitourinary Medical Oncology (GUMO) 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 Genitourinary Medical Oncology (GUMO) 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 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.
Expert 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.

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 Genitourinary Medical Oncology (GUMO) Program clinical trials. This individual will be responsible for overseeing the management of approximately 30 active clinical trials, in addition to the start up of an additional 10-20 clinical trials at any given time. At any one time up to 75 oncology patients will be enrolled on these clinical trials.

Regulatory Affairs
This position has the responsibility for ensuring that the Genitourinary Medical Oncology (GUMO) 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 Projects as assigned
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
REQUIREMENTS:
Bachelor's Degree in science or a health related field plus a minimum of 2 years of regulatory affairs experience

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.
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.
CONDITIONS OF EMPLOYMENT
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.
The University of Washington is a leader in environmental stewardship & sustainability
, and committed to becoming climate neutral.
The University of Washington is an equal opportunity, affirmative action employer.
To request disability accommodation in the application process, ****-543-6452 (tty) or ****

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