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.

The University of Washington's Division of Medical Oncology's includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, 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.

Department of Medicine: Oncology has an outstanding opportunity for a full-time Regulatory Coordinator to join their team.

POSITION PURPOSE
This position will provide regulatory support and study initiation support to the Sarcoma Research Program. At any given time, there will be approximately 40 active clinical research trials and anywhere from 10 to 20 trials in the process of being activated. This position will oversee all aspects of implementation, 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: the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington, in addition to the governmental regulatory requirements. This position will oversee the regulatory management of phases I-IV industry, investigator-led, and NIH sponsored research studies.

The purpose of this position is to manage and administer the regulatory affairs of the Sarcoma Program. This position will work closely with the Regulatory Affairs 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.

POSITION COMPLEXITIES

This position is required to use independent judgment, leadership and knowledge of the academic clinical trial healthcare regulatory operations to effectively facilitate the workflow 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.

This position is supervised by and reports to the Regulatory Affairs Manager for the Sarcoma Program.

This position will work with minimal supervision in performing work assignments and will work closely with the Research 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 correctly navigated through the institutional start up procedures, and 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, FHCRC, SCCA, and Harborview departments and staff.

This position is key to the success of the Sarcoma 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 Sarcoma Oncology clinical trials, the majority of which provide significant financial support for the Division of Oncology.

DUTIES AND RESPONSIBILITIES
Regulatory Affairs - 90%

Responsibility for the Sarcoma Program regulatory requirements, and significant involvement in clinical trial implementation/study start-up. This will necessitate research protocol submissions to various institutional committees, internal 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. This position will be integral in study initiation activities, and will manage coordination of study start-up efforts .

Coordinates regulatory affairs management as outlined by protocol objectives.

Write/edit clinical research trial consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate “Elements of Informed Consent”. Translate complicated research protocol requirements into language easily understandable by research participants.

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

Contributes to the development and maintenance of the clinical trial budgets.

Prepares and submits documents for Scientific Review Committee, as well as several other internal revisional boards

Assists with facilitation of Confidentiality Disclosure Agreements and Clinical Trials Agreements, as well as with any amendments to these documents

Prepares and submits documents for Human Subjects review

Maintains required regulatory documents (FDA Form 1572 and/or 1571, Protocol Signature Page, Investigator Brochure, Financial Disclosure, Delegation of Authority logs, Training logs, 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.

Meets with internal and industry study monitors to complete reviews of regulatory affairs, and addresses any questions or concerns in a timely manner

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.

Queries and maintains the Program Regulatory Database.

Coordinate clinical research monitoring visits when appropriate, interacting with pharmaceutical sponsors, physicians, investigational pharmacists, and study staff.

Work collaboratively with the research team to ensure that projects are executed successfully and completed within required time frames to meet research objectives

Involve physician leadership as appropriate to ameliorate bottlenecks within clinical trial implementation. Use problem solving and interpersonal skills to assist with organized process improvement efforts.

Create and manage study records, including management of study binders, source documentation, and incoming paperwork. This includes generation, completion, and review of patient specific documentation.

Maintain knowledge and understanding of all active Sarcoma clinical trials to ensure regulatory compliance.

This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position 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.

May direct or guide the work of a student helper.

Other Projects as assigned - 10%

MINIMUM REQUIREMENTS

Bachelor's Degree in Biology or health/science related filed and one year experience in clinical research setting

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

ADDITIONAL REQUIREMENTS

Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete within 30 days of hire.

DESIRED QUALIFICATIONS

Previous experience working with Western Institutional Review Board or Fred Hutchinson Institutional Review Board.

Knowledge of IRB submission procedures, FDA and NIH requirements relating to research involving human subjects.

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

Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance research processes a plus.

WORKING ENVIRONMENTAL CONDITIONS
The ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities. This position may include remote work as determined by the needs of the program.

There may be meetings or appointments over which an individual has no control that require a flexible schedule in order to accommodate, such as patient coordination needs, 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 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.

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.