RESEARCH COORDINATOR (2 positions)

University of Washington Shoreline, WA
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. All of which has allowed the UW to be nationally recognized as a "Great College to Work For" for four consecutive years.

The Department of Radiation Oncology at UW Medicine is an academic department specializing in the research, teaching, and providing of professional services for the management of cancer patients undergoing treatment using radiation therapy as the main modality of treatment. The department is an integral part of the Cancer Program at the University of Washington and a major contributor to the contribution margin of each of the six centers at which we provide professional services: University of Washington Medical Center (UWMC); the Gamma Knife facility at Harborview Medical Center (HMC); the Seattle Cancer Care Alliance (SCCA); the Radiation Oncology Suite on the Northwest Hospital Campus (SCCA@NWH); the SCCA Seattle Proton Therapy Center (SPTC); Seattle Children's Hospital (SCH); and the Seattle Puget Sound VA Medical Center.

The Department of Radiation Oncology currently has an outstanding opportunity for (2) full time RESEARCH COORDINATOR to provide professional-level support for clinical research studies and works independently to provide study coordination including screening of potential patients for study eligibility, presenting non-medical trial concepts and study details to patients, and facilitating the informed consent process. Responsible for compiling and reporting of protocol activity, accrual data, workload at regular research staff meetings. Assists in research protocol development, study submissions, and ongoing reporting requirements which include but not limited to: maintaining research files and documentation to complete the regulatory filing. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) (Cancer Consortium Institutional Review Boards at Fred Hutchinson and University of Washington), Industry, institutional departments: Scientific Review Committee, Clinical Research Budget and Billing, and Office of Sponsored Programs.

Primary Job Responsibilities:

* Guide Physicians with all aspects of the study development involving investigator initiated trials, Industry-funded trials, NCTN trials, and retrospective chart review studies

* Establish and maintain contact with Physicians and patients regarding protocol requirements (to maintain adherence to protocol) during work up, enrollment, treatment, and long term follow up.

* Provides study coordination including screening potential patients for study eligibility, presenting non-medical trial concepts and study details to patients, and facilitating the informed consent process

* Compiles and report study information related to protocol activity, accrual date, workload, and other research information at regular research staff meetings

* Responsible for accurate and timely data collection, documentation, entry, and response to sponsor queries

* Submission of regulatory documents which include but not limited to: new study application, amendments, annual reviews, compliance reporting, and adverse events

* Maintains regulatory documentation and regulatory binder filing

* Maintains required credentialing documentation for participation of all UW-affiliated medical institutions, such as investigator information, site certifications, annual accrual figures, and any other procedural requirements necessary for continued participation in various current and/or future clinical trials.

* Participates in monitoring and auditing activities.

* May assist in budget development, review of clinical research budget and research billing charges, and reconciliation.

* Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.

* Maintains research practices using Good Clinical Practice (GCP) guidelines.

* Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Minimum Requirements:

Bachelor's Degree in a biological science or related field, and two years of experience in program management of a research project; OR equivalent education and experience. Knowledge of FDA and NIH requirements relating to research involving human subjects, experience in clinical trial development, implementation and analysis, excellent written and verbal communication skills, experience with Microsoft Word, Excel and Access.

Additional Requirements:

Ability to read and interpret medical and surgical records; ability to understand research protocols; excellent interpersonal and communication skills; willingness to adhere to Departmental Standard Operating Procedures for conducting clinical research; familiarity with the ethical principles of clinical research including issues of patient and sponsor confidentiality; ability to work in a team.

Desired:

Certification in SoCRA, ACRP. Previous work in research study coordination or experience working in an IRB or experience with working in CRBB. Experience in clinical research in the operating room or on a medical/surgical floor; knowledge of cancer staging; basic understanding of clinical research procedures and study design; basic understanding of radiation oncology, medical oncology, and surgical oncology.

Condition of Employment:

This position may be required to work off site at any or all of the participating UW-affiliated sites. In addition to the normal work hours, this position must be willing to work evenings, weekends, and to potentially attend the semi-annual national group meetings and other such meetings as may be required by protocol sponsors.

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.REQUIREMENTS:Bachelor's