Research Coordinator 2

University of Washington•Seattle, WA

5d•Onsite

About The Position

The Department of Radiation Oncology has an outstanding opportunity for a full-time Research Coordinator. This position needs to 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.

Requirements

Bachelor’s Degree in biology, other related science/medical or Health Information Management
Two years of relevant patient-facing clinical research experience in a clinical setting.

Nice To Haves

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.
Certification on SoCRA, ACRP.
Previous work in research study coordination or experience working in an IRB or experience with working in CRBB.
Ability to adapt quickly to changes in work requirements and assignments; must exhibit diplomacy and compassion.

Responsibilities

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), residents, fellows 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.
Work in a fast paced environment, in conjunction with multi-disciplinary teams (medical oncology, radiology, laboratory, etc) to meet the clinical needs of patients while enrolled in a clinical trial.
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.
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.
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 IRBs, 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 compliance, in conjunction with regulatory coordinator, with all FDA and IRB regulations and documentation requirements for each participating UWMC-affiliated institution.
Administer Neurocognitive 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.
Review of CTO, FHCC and vendor charges; ensure correct charges go to study as required.
Catalog and document review of charges to protocols as needed, in conjunction with financial team.