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The Division of Gastroenterology in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator.

Under the general supervision of the Principal Investigators, the Research Coordinator will be responsible for research studies involving subjects with Gastroentestinal Disorders. This position will be responsible for initiated study activity including the management of compliance requirements and clinical unit activities for the research projects of the division. The person in this position will implement and facilitate clinical research studies requiring extensive collaborative efforts for investigator initiated and pharmaceutical- sponsored clinical trials.

The person in this position will evaluate and perform all necessary requirements to implement these clinical research studies. This includes enrolling (identifying, screening, and consent) study subjects, working with other researchers and hospital staff to implement research specific protocols and procedures, and analyzing & reporting results of studies. The position also necessitates the timely completion of all Institutional Review Board and regulatory documents – preparation and submission of new protocols, modifications, and annual renewals.

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 faculty, staff, and regulatory authorities, as well as direct interaction with the FDA. This research program adds to the intellectual environment at the University by the investigators’ participation in research seminars and classroom lectures, as well as providing a training environment for physicians, nurses, and pharmacists. Many of the patients enrolled in these studies are particularly common in the disadvantaged populations served by Harborview Medical Center, having a research clinic at Harborview provides an opportunity for individuals from these populations to participate in research studies giving them a higher quality of life.

RESPONSIBILITIES
This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, Investigational Drug Services, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 20 projects will be in progress simultaneously, with the expectation of additional projects in the future.

Patient Management (40%):
Patient enrollment including identification, screening and consent of subjects. Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers. Oversight of collecting and recording clinical data from a combination of electronic medical record systems review, and participant and physician interviews. Network with other organizations to improve study recruitment.

Protocol Development and Implementation (30%):
Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project. Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable for the individual patient Works collaboratively with study team members and outside sites to develop and coordinate the development and implementation of the study design and other protocol required information.

Protocol Management (20%):
Independently develop and implement research project policies and procedures that meet research objectives that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA). Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines. Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives. Take action to correct problems such as deviation from protocol requirements to ensure research quality. Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.

Analysis and Reporting (10%):
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion. Manage a confidential clinical research database including data cleaning and quality assurance processes In collaboration with the principal investigators, generate reports for granting agencies and Institutional Review Board annual renewals/modifications; for sponsoring agency, steering committee membership; and for scientific presentations and manuscripts Obtain necessary regulatory and compliance approvals.


MINIMUM REQUIREMENTS
•Bachelors Degree in Science or related field.
•2-3 years related experience in an academic hospital/research clinic setting.
•Ability to work independently.
•Experience with Human Subjects research Experience with Institutional Review Board applications and modifications.
•Experience with direct communication between sponsors in regards to study, auditing purposes, reporting adverse events, etc.

Equivalent education and/or experience may substitute for minimum requirements.

DESIRED REQUIREMENTS
•Demonstrate a track record of excellent organizational skills and meticulous research-related work, preferably on NIH- funded research grants involving clinical research protocols and industry-sponsored clinical trials.
•Work collaboratively with study investigators and study staff at multiple sites of enrollment, hospital clinical and administrative staff, as well as participants and families to coordinate recruitment, enrollment, and data collection.
•Exhibit excellent interpersonal skills, with ability to interact with potential study subjects with sensitivity, tact, and impeccable judgment.
•Prior working relationships with industry sponsors including but not limited to: Gilead, Novartis, Lumena, Salix, Aptima, Roche, Merck, Janssen, Abbvie, BMS, Vital Therapies, Conatus, Bristol Meyers Squibb, and Vertex.
•Prior experience working with Investigator-Initiated Research Studies.
•Accurate, detail-oriented, organizational skills with experience in the development and implementation of standard operating procedures for clinical research groups.
•Ability to synthesize materials for multidisciplinary faculty, regulatory authorities and staff.

CONDITIONS OF EMPLOYMENT
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.