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Radiation Oncology has an outstanding opportunity for a Research Coordinator to provide regulatory support to the UW Radiation Oncology Clinical Research Team consisting of 6-8 clinical research coordinators and 2 data coordinators. At any given time, there will be up to 50 active clinical research trials/research projects and up to 15 trials in the process of being activated.
This position will support 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. This position will support the regulatory management of Phases I-III industry-initiated, investigator-initiated, and federally sponsored research studies.
This position is critical to the success of the UW Radiation Oncology Clinical Research Team and will be instrumental in providing oversight of all research regulatory compliance. This position will not only impact these research programs but also the Department of Radiation Oncology ensuring compliance with all regulatory requirements. It will require a strong partnership with faculty and staff within and external to the program.
This position is supervised by and reports to the Clinical Research Manager of the UW Radiation Oncology Clinical Research team. This position will work in close alliance with all members of the Clinical Research Team.
•Work with the Clinical 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. •Support, 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, CVs, medical licensures, delegation of authority logs, and related forms per sponsor or federal requirements). •Work with the Clinical 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 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 translational research projects and chart review projects. •Maintain knowledge and understanding of all active UW Radiation Oncology clinical trials to ensure regulatory compliance. •Perform related tasks as assigned.
•A Bachelor's degree in life or social sciences or related field plus a minimum of 2 years regulatory affairs or research coordination experience. •Sound 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 multitask, 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.
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 translational research projects. •Understanding of theoretical objectives of clinical research projects. •Strong interpersonal communication skills to work effectively with study sponsors, investigators, and research personnel involved in research projects. •Excellent organizational skills and ability to track and manage multiple competing deadlines •Understand research protocols and translate research needs into appropriate regulatory requirements •Ability to work independently and with a team •Superb attention to detail
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. •Experience with WIRB.
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 multitask and be flexible while maintaining professionalism is crucial as priorities change throughout each day. May have to respond to multiple requests for information (email, 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 team needs, grant deadlines, and faculty needs.
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.
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