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The Division of Hematology has an outstanding opportunity for a full-time Regulatory Coordinator.
This position will provide regulatory support to the UW Hematology Research Program. This position will work with 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 pharmaceutical sponsors, funding foundation or governmental agency. In addition, this position will have knowledge of and represent our 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.
This position requires knowledge of protocol requirements as set forth by federal regulations, knowledge of the academic clinical trial healthcare regulatory operations to effectively facilitate the work flow and promote a collaborative work environment. The position requires effective 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 Manager of the UW Hematology Clinical Research program and works in close alliance with all members of the program. Under administrative direction as our 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 coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines. This position is required to coordinate efforts across the alliance partners including UW, SCCA, FHCRC and at times Seattle Children’s Hospital.
This position will work with the Research 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 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.
This position is critical to the success of the UW Hematology Clinical 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 Hematology 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:
Knowledge of FDA, Code of Federal Regulations, and Good Clinical Practice 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.
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 Hematology. The regulatory coordinator is responsible for overseeing the regulatory affairs of the UW Hematology Clinical Research Program's clinical trials and research studies. This individual will be responsible for overseeing the regulatory coordination of ~50 active phase l-lll clinical trials, in addition to the startup of an additional 1-15 clinical trials.
Duties and Responsibilities:
Overall responsibility for ensuring the UW Hematology Clinical Research Program’s 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.
Maintain and update all required regulatory documents (FDA Form 1572 and/or 1571, protocol signature page, Investigator’s Brochure, financial disclosures, laboratory accreditations, laboratory reference ranges, investigator and research staff CVs, medical licensures, delegation of authority logs, and related forms per sponsor or federal requirements).
Maintain and audits study-specific regulatory files and location-profile filing system per FDA guidelines.
Work with the Research 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 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.
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.
Monitor, distribute and maintain safety documents including Investigational Drub Brochures IND safety reports and Serious Adverse Events (SAE) reports
Maintain 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.
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 1 year regulatory affairs or research coordination experience.
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. Be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects. Maintain positive 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
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 while maintaining a professional demeanor is crucial as priorities change throughout each day. May respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.
Work hours can 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 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.
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