Research Coordinator, Radiation Oncology: Clinical Trials

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.
Provide professional-level support for clinical research studies open in Radiation Oncology; assist in protocol development, support investigativer procedures, assist in implementing protocols, and meet reporting requirements of the Scientific Review Committee (SRC), Institutional Review Boards at Fred Hutch and University of Washington (IRBs), Clinical Research Budget and Billing (CRBB), Office of Sponsored Programs (OSP) and Industry Sponsors and National Cancer Institute (NCI)
Independently, process and coordinate the operations of research studies. This requires the knowledge and skills specific to conducting research protocols. Assist investigators with submission of research studies to SRC, IRG, CRBB, and the Radiation Safety Office (RSO) to meet all regulatory and compliance submissions involving editing of investigator initiated protocols and consent forms as well as submission of NCI cooperative group protocols and industry protocols. Set up and implementation of SOPs as needed to meet the requirements of and adherence to protocols.
The impact to the University will be that all Radiation Oncologists in the Department of Radiation Oncology will receive support in opening and running their investigator initiated and industry trials in a more efficient and timely manner while continuing to support cooperative group trials through the National Cancer Institute Grant.
DUTIES AND RESPONSIBILITIES

Guide MDs with all aspects of the development of investigator initiated studies.

Where required, assist MDs with retrospective chart review studies by their medical students.

Submit and maintain regulatory requirements of Industry Sponsored Trials.

Submit cooperative group protocols and industry sponsored protocols as required.

Must be familiar with all aspects of regulatory and compliance functions: initial submission to SRC, IRB, CRBB/OSP as pplicable, and RSO.

As mandated by IRGs, meet Annual review deadlines, meet deadlines for amendments, compliance deviation reporting, study deviation reporting, reporting of SAEs that occur with study patients, and reporting of 3rd party SAEs.

Maintain all required documentation for participation of all UW-affiliated medical institutions, such as investigator information, site certification, annual accrual figures, future applications for full NRG member status and any other procedureal requirements necessary for continued participation in the NRG and various current and/or future CLINICAL TRIALS.

Initiate/maintain compliance with all FDA and IRB regulations and documentation requirements for each participating UWMC-affiliated institution.

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

Implement research protocols by writing and maintaining SOPs to maintain Investigator and Patient compliance. Monitoring patient adherence to the protocol by providing compliance calendars, study calendars. Take action to correct problems such as deviation from protocol requirements (and report deviations per IRB requirements).

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

Catalog and document all designated clinical trial protocols currently accruing at UW-affiliated sites, and to update clinicians about other new/available clinical trial protocols.

Abstract data from clinical records and submit data per the sponsor’s requirements; review, maintain and meet all requirements of SOPs to maintain audit readiness.

Collect all case report forms, patient charts, radiographs, pathology specimens, and other clinical data pertinent to successful participation in CLINICAL TRIALS, as mandated by study protocols.

Review of CRBB charges; ensure correct charges go to study as required.

Catalog and document CRBB review of charges to protocols as needed.

Administer Neurocognative Tests and Quality of Life Questionnaires or other tests per individual protocol requirements.

Provide assistance with auditing process from outside agencies as needed.

Perform related duties as required.
MINIMUM REQUIREMENTS

Bachelor’s Degree in biology or other related science/medical or Health Information Management plus 2 years' experience; OR equivalent combination of education and related experience
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

Must have worked in previous positions that require excellent organizational and communication skills in medical or related field and have some knowledge of regulatory requirements as it applies to research.
DESIRED QUALIFICATIONS

Certification on SoCRA, ACRP. Previous work in research study coordination or experience working in an IRB or experience with working in CRBB.
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.