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The Department of Medicine’s Division of Gastroenterology has excellent opportunities open for Temporary, Full-Time/Project-TermResearch Coordinators to manage coordination of phase I and phase II limited-term research studies involving subjects with inflammatory bowel disease.
Job duties include:
Study Management (70%)
•Manage research subject participation including consenting, oversee study-related databases, supervise the input of data, report design and review outcome and adverse event patterns. •Manage implementation and ongoing activities of clinical trials such as Screening, Recruitment and Enrollment of patients. •Oversee research protocol activities carried out by physicians as directed by the Research Manager and Lead Research Coordinator. •Source documentation creation management. •Assess documentation of all adverse events, determine severity and report events to PI and IRB. •Take action to correct problems such as deviations from protocol requirements to ensure research integrity. •Ensure that projects are executed successfully and completed within required time frames to meet research objectives. •Process labs for clinical trials, including collecting, centrifuging, and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations. •Facilitate study site visits and ensure all required documentation is available for auditors and monitors. •Enter study data on paper or electronic case report forms (eCRF’s). •Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. •Maintain study financial records
Regulatory Compliance & Budget Development (25%)
•Ensure study compliance with institution and state regulatory and financial guidelines •Verify accuracy of program budgets and implement corrective action as needed •Monitor study/project budgets •Liaison with funding agencies as needed
Other related duties as assigned (5%)
Minimum qualifications: Bachelor's Degree and one year of relevant work experience or equivalent combination of education and experience.
Desired qualifications: •Experience using electronic data submission software. •Sound knowledge of Microsoft Office, Word, Excel. •Experience in clinical trial processes, implementation of research protocols and excellent written and verbal communication skills, and attention to detail. •Able to work independently and be a team player; to maintain positive vision, sense of humor, and flexibility; to multi-task and as priorities change, maintaining a professional demeanor at all times. •Proficiency with medical terminology •Prior experience working with Inflammatory Bowel Disease and/or other gastrointestinal conditions •Familiarity with Good Clinical Practice (GCP) •Proficiency with phlebotomy •CPT and general coding experience •Clinical/Medical billing expertise •Familiarity with University of Washington financial systems (i.e. EPIC, MyFD, CRBB, GrantTracker, Award Status Checker,etc.).
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