JOB DESCRIPTION

Provide professional-level support for clinical research studies open in Radiation Oncology; assist in protocol development, support investigative 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).

REQUIREMENTS:

• Bachelor’s Degree in Biology or other related science/medical field and four years of relevant experience.
  Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

50% 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 applicable, 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.
35% Function as lead support to the clinical research coordinator team and to PIs. As CRC lead, this position will support PIs with projects that are unusually complex in nature due to the clinical protocols, the volume of expected enrollees, the volume of data to be collected, the number of other sites participating in the study, or the time frame for completion. As CRC lead within the clinical research coordinator group, responsibilities will inlcude: mentoring data coordinators and new research coordinators, training on IRB processes, secondary review of research protocols as needed, periodic auditing of study documentation and representing the CRC Manager in their absence on committees or project audits when requested.
15% Provide typical support for clinical research studies including: 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.
Administer neurocognitive tests as necessary and approved within the scope of a study.
Function as lead support to the clinical research coordinator team of 7 – 10 FTEs and two PIs. As CRC lead, this position will support PIs with projects that are unusually complex in nature due to the clinical protocols, the volume of expected enrollees, the volume of data to be collected, the number of other sites participating in the study, or the time frame for completion. As CRC lead within the clinical research coordinator group, responsibilities will include: mentoring data coordinators and new research coordinators, training on IRB processes, secondary review of research protocols as needed, periodic auditing of study documentation and representing the CRC Manager in their absence on committees or project audits when requested.