Clinical Research Coordinator

4 weeks 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 University of Washington, Division of Medicine has an outstanding opportunity for a full-time Research Coordinator. The purpose of this position is to promote the research objectives of the Diabetes clinical Research group within the Diabetes Institute. This position works with Division of Medicine faculty to facilitate investigator-initiated and industry sponsor drug and device clinical trials. This position is responsible for implementing multiple research projects in human subjects.

Position Complexities:

This position requires operational knowledge of the University of Washington, a firm understanding of the research process, and an ability to integrate this knowledge with research priorities to implement program goals. The Diabetes Institute clinical research supports a diverse portfolio of clinical research studies with focus on diabetes and its complications, a portfolio of early to late phase clinical trials, and both drug and device interventional studies. This is an excellent opportunity to gain experience as a Research Coordinator in diabetes technology and pharma studies. This position is managed by and reports to Senior Clinical Research Coordinators and the Research Manager.

Position Dimensions and Impact to the University:

Our group provides investigator support on all aspects of type 1 and 2 diabetes for investigator initiated, government, and industry sponsored clinical research studies. We support and manage Human Subjects, regulatory, and financial oversight to ensure efficient execution of studies with the highest quality data.

DUTIES AND RESPONSIBILITIES

Protocol Management - 50%

With minimal guidance implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution and federal regulations. This position will be responsible for all aspects of multiple clinical trials, including patient recruitment and management, study data collection and management, and study administration.

Develop, document, and maintain procedures for patient registration and activities, and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.

Coordinate and conduct study visits and activities, record and collect study data, complete data entry, maintain study source records, and resolve queries based on source documentation.

Work with Regulatory Coordinator to develop and implement study tools and source documents, maintain regulatory documents, and review and complete regulatory submissions to Institutional Review Boards and other regulatory and reviewing boards.

Work collaboratively with the research team (regulatory coordinator, research assistants, senior diabetes specialists) to ensure that projects are executed successfully and completed within the required time frames to meet research objectives and metrics.

Data & Patient Management - 30%

Responsible for facilitating and tracking study visits, tests, and procedures in accordance with the protocol, ensuring billing compliance, and accurate and complete data collection, including informed consent forms and source documentation.

Obtain, abstract, and code clinical information from multiple sources (medical records, research records, etc) for research participants in order to enter data into study specific data capture systems, and to document, assess, and report adverse events and safety data to study investigators, sponsors, IRB's and other regulatory authorities when applicable.

Work with monitors and sponsors to facility study site visits, and, and with limited guidance to develop and implement corrective action plans to ensure protocol adherence, and data integrity, and to resolve queries in a timely manner.

Communication & Administration - 20%

A good working knowledge of each protocol, and familiarity with patient populations, diseases, and clinical service line operations necessary to manage assigned study portfolio.

Effective and timely communication with industry sponsors and sponsor affiliates, physicians, clinical service lines, and patients is an essential part of this position.

This position will independently manage multiple projects simultaneously, routinely work under specific timelines or deadlines, with specific timelines or to meet deadlines, and often may require a high degree of prioritization and adaptability.

MINIMUM REQUIREMENTS

Bachelor's degree in Biological Sciences or a related field or equivalent combination of education and experience AND at least two years of related experience.

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

ADDITIONAL REQUIREMENTS

Prior experience working with patients and/or the public or healthcare providers in a healthcare setting.

Excellent communication with proficiency in English and organizational ability.

Prior experience with industry-sponsored clinical trials preferred.

Experience with diabetes technologies including pump and CGM preferred.

CONDITIONS OF EMPLOYMENT

Office and participant visit location in the UW Diabetes Institute F Building.

May require climbing stairs to access office location.

Must have flexibility to meet programmatic needs by adjusting work schedule.

Ability to travel to meetings off site.

Application Process: The application process 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 access 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.

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