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Research Coordinator

4 months ago

Seattle, United States University of Washington Full time

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.

The Department of Medicine's Division of Gastroenterology has an outstanding opportunity open for a Temporary Research Coordinator.

Under the general supervision of the Research Manager and Principal Investigator, the Research Coordinator will be responsible for research studies involving subjects with Inflammatory Bowel Disease. The person in this position will be responsible for initiating study activity, including the management of compliance requirements and clinical unit activities for the UWMC IBD Research Program. The person in this position will implement and facilitate clinical research studies requiring extensive collaborative efforts with the funding agency (NIH, private foundations) and pharmaceutical companies.

The Research Coordinator position requires knowledge of FDA, IRB, and local regulations related to the conduct of research studies. In addition, this position requires knowledge of the condition under study and the ability to interact and care for patients with chronic illnesses. Furthermore, this position requires the ability to interact and collaborate with internal and external representatives from a wide variety of fields.

This position requires a detailed knowledge of FDA and clinical trial guidelines in order to conduct research at the University of Washington in compliance with these regulations. In addition, this position requires frequent interface with a number of institutional representatives, regulatory authorities, and direct interaction with the FDA.

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%)

Qualifications

Minimum Qualifications

* Bachelor's Degree in related field and one year or less of experience
* Experience using electronic data submission software.
* Sound knowledge of Microsoft Office, Word, Excel.

Specify the type of experience required

* 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.).

Application Process:

The application process for UW positions 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.