Salary is commensurate with experience and education
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The Division of Hematology has an outstanding opportunity for a full-time Regulatory/Post Award Fiscal Coordinator. This position will provide regulatory and study fiscal support within the Division. At any given time, there will be up to 35 active clinical research trials/research projects and anywhere from 1 to 10 trials in the process of being activated. This position will oversee all aspects of study start-up, submission and continuous reporting to the relevant regulatory agencies, including Institutional Review Boards, the Food and Drug Administration (FDA), the Institutional Biosafety Committee, the institutional Radiation Safety Committee and the pharmaceutical sponsors, funding foundation or governmental agency and will perform fiscal activities including but not limited to purchasing, patient travel, invoice payment, reimbursement, and monthly reconciliations. 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. This position will oversee the regulatory and fiscal management of Phases I-III industry-initiated, investigator-initiated, and federally-sponsored research studies.
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 trials research manager. 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. This position will need to understand 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 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 consortium partners including UW, SCCA, and FHCRC departments and staff.
This position will work with the research managers to create and maintain program Standard Operating Procedures (SOPs)/guidelines, as well as ensure program compliance with the SOPs/guidelines. This position may also perform Quality Assurance checks on regulatory files as needed and implement/maintain appropriate 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 will be instrumental in providing oversight of all research regulatory compliance for 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.
This position works with Division of Hematology faculty to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.
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. Assist in the development of protocols for therapeutic clinic trials as well as minimal risk translational research projects and chart reviews.
Knowledge, Skills and Abilities:
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.
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.
Regulatory and Fiscal Responsibilities:
Responsible for ensuring research trials and projects meet regulatory requirements and are compliant with federal and institutional policies and that fiscal activities are appropriate from award to closure. This is critical for ensuring the quality of the research, the reputation of the institution, and patient safety. This position will 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 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.
Perform fiscal actions for clinical research budgets including but not limited to purchasing, patient travel, invoice payment, reimbursement, and monthly reconciliations. Maintain and process travel expense records; ensure compliance with state and institution regulations and procedures; allocate travel expenses to appropriate budgets. Maintain documentation in accordance with established recordkeeping systems, including following strict guidance for scanning and maintaining electronic documentation. Set up new budget files. Maintain current knowledge of University purchasing policies and procedures
Maintain and update required regulatory documents (FDA Form 1572 and/or 1571, protocol signature page, Investigator's Brochure, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and related forms per sponsor or federal requirements). Work 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.
Collaborate with the Research Managers on study start up activities. Including IND, IDE, and exemption submissions
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.
Maintain knowledge and understanding of all active clinical trials to ensure regulatory compliance.
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 Business, science or related field
Two years' experience with clinical research budgeting, regulatory, or related research or healthcare experience
Ability to work effectively and efficiently in a group environment
Exceptional organizational and customer service skills
Strong written and oral presentation skills
Ability to communicate effectively with all levels of faculty, management and clinical research staff
Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely
Ability to prioritize and organize work independently
Demonstrated skill in using Microsoft Excel
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience in an academic medical center
Experience with fiscal work
Experience in Hematology clinical research
Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols
Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations
Experience with using International Classification of Diseases, 9th Revision (ICD-9), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment Strong working knowledge of Microsoft Office Suite
CONDITIONS OF EMPLOYMENT
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.
Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day. Projects may require travel between affiliate locations to facilitate budgeting communication.
The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchison Cancer Research Center campus.
This position requires a flexible work schedule. Stringent deadlines from sponsor organizations/companies, to meet deadlines may require overtime including occasional evening and weekend overtime.
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, Criminal Conviction History, 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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