Regulatory specialist Jobs in Seattle, WA

REGULATORY COORDINATOR

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Department of Medicine : Hematology and Oncology has an outstanding opportunity for Regulatory Coordinator.

Position Purpose :

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.

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 60 active clinical research trials / research projects and up to 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 (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), Seattle Cancer Care Alliance (SCCA), and Fred Hutchinson Cancer Research Center (FHCRC), 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, SCCA, and FHCRC departments, federal agencies and industry partners.

This position is supervised by and reports to the Clinical Research Program Manager 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, SCCA, and FHCRC 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.

RESPONSIBILITIES :

Regulatory Affairs- 90%

Other tasks as assigned -10%

MINIMUM REQUIREMENTS :

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

ADDITIONAL REQUIREMENTS :

DESIRED :

WORKING CONDITIONS :

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.