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Req #: 241188

Department: SCHOOL OF MEDICINE

Job Location Detail: Hybrid eligible: Worksites may include UWMC - Montlake, Harborview Medical Center, UWMC - Northwest and Roosevelt Clinic. Expected to be onsite for research activities. Remote options are variable depending on projects.

Posting Date: 11/25/2024

Closing Info: Open Until Filled

Salary: $4,736 - $6,700 per month

Shift: First Shift

Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf)

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 Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SoM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.

The Clinical Trials Office has two outstanding opportunities for a Clinical Research Coordinator 1 (CRC-1) to support research studies in its Research Coordination Center (RCC).

The CTO provides support and education to help investigators improve the quality of their research and ensure compliance with federal, state, and institutional regulations. The CTO Research Coordination Center provides support to clinical researchers from the six health sciences schools and others across our partner institutions. The RCC provides assistance with investigator-initiated biomedical or behavioral studies as well as pharmaceutical and biotech industry sponsored clinical trials. The RCC is designed to support investigators with their research projects by assisting with the IRB approval process and the design and implementation of investigator initiated and industry-sponsored research protocols.

The CRC-1 interacts with numerous staff, patients, study participants, and faculty. The person in this role must exhibit an appreciation of, a sensitivity to, and respect for a diverse academic and clinical environment, inclusive of patients, faculty, and staff of many social, economic, cultural, ideological, racial and ethnic backgrounds. The position requires a high degree of flexibility and the ability to work in a variety of settings and locations. The CRC-1 will support multiple medical specialties and will likely work on 1-5 studies simultaneously depending on the complexity of the assignments. The CRC-1 will be responsible for parts of these studies, working in tandem with, and oversight from, other senior clinical research staff. Comprehensive training will be provided for this position.

This CRC-1 position works integrally with the Human Subjects Division, CTO Finance, the Office of Sponsored Programs, and other research support departments such as Investigational Drug Services and the Translational Research Unit within the University. This position coordinates technical and administrative details of clinical research studies, including phase I-IV clinical trials, and assists Principal Investigators (PI) in maintaining study integrity and achieving study objectives through successful implementation and completion of protocols and procedures.

DUTIES AND RESPONSIBILITIES Research Operations Support - 80%:

• Assist with the design, creation and revision of research instruments as necessary to ensure quality data that correlates with research objectives; coordinate multiple protocol-specific data collection efforts for one or more research projects which may include other collaborating agencies or institutions.

• Assess study protocols for clarity and subject safety, review inclusion/exclusion criteria. Clarify concerns and questions with Principal Investigators and sponsors.

• Attend and participate in investigator and staff meetings. Advise the team regarding specific study assignments and timelines.

• Perform patient screening activities, including phone screening.

• Understand the informed consent process and be able to explain it.

• Consent potential study participants on non-interventional studies and assist with informed consent on interventional trials.

• Review patient source data and obtain medical history and demographics.

• Maintain study data, status reports, progress notes, and subject log to help ensure subject safety.

• Plan subject visits and coordinate related facility and equipment availability.

• Track and report adverse events (AE).

• Document protocol deviations.

• Assist with study closeout activities.

• Complete sponsor case report forms (CRFs) and resolve sponsor queries.

• Maintain study documents in compliance with FDA guidelines.

• Assist with proper collection, processing, and shipment of specimens.

• Perform additional clinical research functions and assist research team members as required.Regulatory Support – 15%:

• Assist with maintenance of IRB approval for investigators.

• Assist with preparation and submission of IRB applications and study documents for IRB review.

• Assist with regulatory, budgetary, contractual, and other aspects of protocol implementation in compliance with applicable federal regulations, institutional policies, and the principles of Good Clinical Practice (GCP).Fiscal Support - 5%:

• Track research activities by study for RCC billing platform.

• Work with departmental financial staff to assist with research invoicing and tracking. MINIMUM REQUIREMENTS

• Bachelor’s degree in biological science or health related field or equivalent combination of education and work experience.

• At least one year of clinical or research experience or other applicable research project management or research customer experience. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS

• Completion of assigned Human Subjects Protection, Good Clinical Practice, and onboarding coordinator training within 6 months of start date.

• Excellent written and verbal communication, including patient interactions, consulting, and customer service skills.

• Proficiency with standard MS Office software, including Word, Excel, Access, and Power Point.

• Strong internal and external customer service skills.

• Ability to adapt and respond appropriately to competing priorities in a fast-paced environment.

• Self-motivated, self-starter who takes initiative to improve existing processes. DESIRED QUALIFICATIONS

• Medical Assistant or Phlebotomy certification in the State of Washington.

• Fluency in a language other than English.

• Experience with community engagement.

• Experience in clinical research ethics and/or human subjects protection. WORKING ENVIRONMENT CONDITIONS

• The CRC-1 will be located at UWMC-Montlake but may work at a variety of sites depending upon the location of a specific project. This position will primarily be onsite with limited flexibility for remote work when available.

• Work sites for this position may include the University of Washington Medical Center (both Montlake and Northwest locations), Harborview Medical Center, South Lake Union, and UW Neighborhood Clinics. 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.

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.