U

University of Washington

Public research university in Seattle, WA

Research Coordinator 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeSeattle, WA, USA$66k - $78k /yrIn-person

About the Job

Requirements

  • A bachelor's degree in biology, another related science or medical field, or Health Information Management.
  • Two years of relevant patient-facing clinical research experience in a clinical setting.
  • Previous experience requiring strong organizational and communication skills in a medical or related field.
  • Knowledge of regulatory requirements as they apply to research.
  • Certification through SoCRA or ACRP is preferred.
  • Previous experience in research study coordination, an Institutional Review Board, or a Clinical Research Review Board is preferred.

Responsibilities

  • Independently process and coordinate the operations of research studies and conduct research protocols.
  • Assist investigators with regulatory and compliance submissions to the SRC, IRB, CRBB, Radiation Safety Office, and other applicable offices, including investigator-initiated, NCI cooperative group, and industry protocols.
  • Set up and implement standard operating procedures required for protocol adherence.
  • Implement research protocols by writing and maintaining standard operating procedures, monitoring patient adherence, maintaining compliance and study calendars, correcting protocol deviations, and reporting deviations according to Institutional Review Board requirements.
  • Maintain contact with physicians, residents, fellows, and patients regarding protocol requirements during workup, enrollment, treatment, and long-term follow-up.
  • Catalog and document clinical trial protocols accruing at affiliated sites and update clinicians about new or available clinical trial protocols.
  • Work with multidisciplinary teams to meet the clinical needs of patients enrolled in clinical trials.
  • Abstract data from clinical records and submit it according to sponsor requirements.
  • Review and maintain standard operating procedure requirements to support audit readiness.
  • Collect case report forms, patient charts, radiographs, pathology specimens, and other clinical data required by study protocols.
  • Guide physicians through the development of investigator-initiated studies.
  • Assist with retrospective chart review studies conducted by medical students.
  • Complete initial submissions, annual reviews, amendments, compliance deviation reports, study deviation reports, serious adverse event reports, and third-party serious adverse event reports as required.
  • Maintain compliance with Food and Drug Administration and Institutional Review Board regulations and documentation requirements for participating affiliated institutions.
  • Administer neurocognitive tests, quality-of-life questionnaires, and other tests required by individual protocols.
  • Assist with audits conducted by outside agencies.
  • Review clinical trial office, Fred Hutchinson Cancer Center, and vendor charges and ensure that correct charges are assigned to studies.
  • Catalog and document protocol charge reviews with the financial team.
  • Perform related duties as required.

Desired Qualifications

  • Previous experience requiring strong organizational and communication skills in a medical or related field.
  • Knowledge of regulatory requirements as they apply to research.
  • Certification through SoCRA or ACRP.
  • Previous experience in research study coordination, an Institutional Review Board, or a Clinical Research Review Board.
  • Ability to adapt quickly to changes in work requirements and assignments, and to demonstrate diplomacy and compassion.

About the Company

University of Washington

Public research university in Seattle, WA

The University of Washington is a public research university founded in 1861, with campuses in Seattle, Bothell, and Tacoma. It provides undergraduate, graduate, and professional education alongside research and public service.

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