Number of Applicants
:000+
Req #:
220305
Department:DEPARTMENT OF MEDICINE: ONCOLOGY
Job Location:Seattle - Other
Posting Date:03/28/2023
Closing Info:Open Until Filled
Salary:$4,300 to $5,400 per month
Other Compensation:Shift:
First Shift
Benefits: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.
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.
POSITION PURPOSE
The University of Washington's Division of Medical Oncology's includes faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center, 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.
The Division of Medical Oncology has an outstanding opportunity for a full-time Regulatory Coordinator. This position will provide regulatory support to the Phase 1 Research Program. At any given time, there will be approximately 50 active clinical research trials and anywhere from 10 to 15 trials in the process of being activated. This position will oversee some 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 affairs requirements mandated by the three Cancer Consortium partner institutions: Seattle Children's Hospital, Fred Hutchinson Cancer Center, and the University of Washington, in addition to the governmental regulatory requirements. This position will oversee the regulatory management of phases I-II industry, investigator-led, and NIH sponsored research studies.
Position Complexities
This position is required to use some independent judgment and should have 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 University and FHCRC departments, federal agencies, and industry partners.
This position is supervised by and reports to the Phase I Regulatory Research Manager.
This position will work with moderate supervision performing work assignments and will work closely with the Regulatory Manager, the Research Manager and Coordinators and Fiscal staff. This position will need to understand the 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 requires some independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance.
The Regulatory Coordinator 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 Alliance partners including UWMC, FHCC, and SCH departments and staff. The Regulatory Coordinator must be able to work with minimal supervision on multiple research projects without benefit of written policies or procedures. This position works closely with the Regulatory Manager and 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. This position is critical to the success of the Phase 1 Research Program and will be providing oversight of 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. A strong partnership with faculty and staff within and external to the program is required.
Knowledge, Skills and Abilities
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.
The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.
To request disability accommodation in the application process, contact the Disability Services Office at View phone number on jobs.ispe.org or View email address on jobs.ispe.org.
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.
COVID-19 VACCINATION REQUIREMENT
Employees of the University of Washington are required to be fully vaccinated against COVID-19 unless a medical or religious exemption is approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen. As a condition of employment, newly hired employees will be required to provide proof of their COVID-19 vaccination. View the Final candidate guide to COVID-19 vaccination requirement webpage for information about the medical or religious exemption process for final candidates.
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