Req #: 228702 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY Job Location: Seattle - Other Posting Date: 11/16/2023 Closing Info: Open Until Filled Salary: $5,000 - $5,850 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 purpose of this position is to manage and administer the regulatory affairs of the Phase I Program. This position will work closely with the Regulatory Phase I Manager, preparing documents for IRB submission of clinical research protocols. This position will coordinate the collection and submission of regulatory and research protocol required documents to Sponsors, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center and the University of Washington. Ongoing regulatory management of various phases of industry, investigator and NIH initiated clinical trials will be part of this position.
This position is required to use independent judgment, leadership and 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 departments, SCCA departments, and the FHCRC departments, federal agencies and industry partners.
Position Complexities
This position is supervised by and reports to the Regulatory Phase I Manager of the Phase I Program.
This position works with minimal supervision in performing work assignments and will work closely with the Regulatory Phase I Manager, the Research Coordinators and Fiscal Analyst in making judgments and decisions within guidelines of UW and sponsor agency policies. This position is constantly required to integrate information from multiple sources to ensure that all research protocols are submitted within the IRB, Cancer Consortium and Sponsor required guidelines.
This position requires independent decision making on all aspects of the research study start up process as well as ongoing regulatory affairs work. This position is required to coordinate efforts across the Alliance partners including UWMC, FHCC, and Harborview departments and staff. This position is key to the success of the Phase I Program. It will require a strong partnership with faculty and staff within and external to the program.
Knowledge, Skills and Abilities

Knowledge of administrative requirements of clinical 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.

Comprehensive knowledge of FDA and ICH guidelines, Standard Operating Procedures (SOP), and Good Clinical Practice (GCP).
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 Oncology. It is responsible for overseeing the regulatory affairs of the Phase I Oncology clinical trials, the majority of which provide significant financial support for the Division of Oncology. Furthermore, at any one time up to 100 oncology patients will be enrolled on these clinical trials.
DUTIES AND RESPONSIBILITIES
This position works with minimal supervision in performing work assignments and will work closely with the Regulatory Phase I Manager, the research coordinators and fiscal analyst in making judgments and decisions within guidelines of UW and sponsor agency policies.
Regulatory Affairs - 95%
Overall responsibility for the Phase I Program research protocols regulatory requirements. This will necessitate research protocol submissions to various 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

Oversees regulatory affairs management as outlined by protocol objectives.

Reviews design of protocols in preparation of research protocol submission to multiple institutional offices

Maintains required regulatory documents (FDA Form 1572 and/or 1571, Protocol Signature Page, Investigator Brochure, Financial Disclosure, laboratory accreditations, laboratory reference ranges, investigators’ and research staffs’ CVs, medical licensures, and related forms for each research protocol

Maintains and audits study-specific regulatory files and location-profile filing system per FDA guidelines.

Monitors, distributes and maintains safety documents including Investigational Drug Brochures IND safety reports and Serious Adverse Events (SAE) reports.

Queries and maintains the Program Regulatory Database.
Other Projects as assigned - 5%
MINIMUM REQUIREMENTS

Bachelor's Degree in Biology or health-related field

Minimum 2 years regulatory affairs experience. Knowledge of IRB submission procedures, FDA and NIH requirements relating to research involving human subjects.

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

Experience in clinical trial processes, implementation of research protocols and excellent written and verbal communication skills, attention to detail and experience with Microsoft Office.

Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete within 90 days of hire.
DESIRED QUALIFICATIONS

Previous experience working with research trial regulatory affairs.

Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance research processes a plus.
CONDITIONS OF EMPLOYMENT
This is a full-time position that may require work outside of standard operating hours to meet programmatic deadlines.
Application Process:The application process 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 Work 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.