Work in Washington Veterans Jobs

Req #: 234312

Department: DEPARTMENT OF MEDICINE: ALLERGY & ID

Posting Date: 05/17/2024

Closing Info: Open Until Filled

Salary: $4,680 - $5,200 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.

POSITION PURPOSE
This position will provide support to both the Principal Investigators and Research Coordinators conducting clinical research at the University of Washington Montlake (UWMC) and Harborview Medical (HMC) Centers. The focus of this research is in solid organ transplant and ICU patients.

Provide in-depth statistical and analytical support in designing Industry, NIH and Investigator initiated studies to most effectively test the research hypotheses and outcomes. Play a major role in writing manuscripts and creating graphic elements of study findings for submission to various scientific journals.

Facilitate federal grant applications and prepare all necessary documentation using NIH-specific guidelines.

Collaborate in determining study costs and building budgets for new studies, while complying with institutional specific billing regulations. Assist in managing current research budgets including reconciling expenses monthly, and ordering lab and office supplies.

Design, develop, document and maintain policies, procedures and research instruments for patient enrollment in clinical research meeting all Institutional, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects.

They will need to work closely with sponsors, study monitors, health care providers and outside agencies regarding all aspects of ongoing research for Industry, NIH and Investigator sponsored studies. Within UWMC and HMC they will work with many different entities and departments to schedule, conduct, and document research study visits.

Work with team to recruit, assess eligibility and enroll eligible potential study participants. Conduct study visits and procedures.

Position Complexities: Broad range of activities that require a diverse skill set, communication with a wide variety of institutions, departments, clinics, healthcare providers, in-depth analysis of complex study data, frequent short timeframe deadlines, contact with patients with potentially transmissible infections and direct interactions with critically-ill patients.

Position Dimensions and Impact to the University: Clinically-oriented research to improve the prevention, diagnosis, and treatment of infections in solid organ transplant patients is of critical importance to the University of Washington's Transplant Programs since UW serves as the WWAMI region's transplant center..

DUTIES AND RESPONSIBILITIES The University of Washington's Division of Allergy & Infectious Disease includes more than 50 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 10 years, clinical and research programs in organ transplant infections have been in place to serve the needs of the regional organ transplant population and to participate in research aimed at improving the prevention, diagnosis, and treatment of infections in organ transplant recipients. The organ transplant infectious disease program is deeply committed to conducting research that aims to better understand and improve the care of infectious complications in transplant patients.

The Division of Allergy & Infectious Disease has an outstanding opportunity for a Research Coordinator in the Organ Transplant Infectious Disease Program. This individual will work with faculty in the Organ Transplant Infectious Disease Program to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This individual is responsible for independently designing and implementing multiple research projects to test hypotheses in human subjects.

A key mission of the Organ Transplant Infectious Disease Program is the conduct of clinical and translational research. At any given time, numerous clinical trials are actively recruiting at the within the transplant program. Under the direction of the Director of the Organ Transplant Infectious Disease Program, this individual will provide professional level support for clinical research studies involving human subjects.

This position requires operational knowledge of the University of Washington and Harborview Medical Center and requires in-depth understanding of the research process and ability to integrate this knowledge with research priorities to implement programmatic goals.

Analysis and Reporting – 70%

• Partner with Principal Investigators at both University or Washington and outside institutions in statistical analysis, presentation and reporting of studies conducted by the research team.

• Write and submit research manuscripts with Principal Investigators from both UWMC and outside institutions for publication from in-depth analysis of study data.

• Assist in compiling and submitting NIH required updates such as Research Performance Progress Reports (RPPRs) and Just-in-Time application addendums.

• Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.

• This position will work with clinical research involving human subjects within UW Medicine and therefore clinical Research Study Coordinator (RSC) training is required. The training requirement for this position includes UW Medicine-specific and general training (GCP, HIPAA, etc.).

• Collaborate with internal and external partners. Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.Protocol Development and Management - 20%

• Independently develop and implement research project procedures that meet research objectives and clearly describe the procedures necessary to test the hypotheses of the project. Ensure compliance with all aspects of Institution, 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 patient registration and protocol 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 satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.

• Formulate Standard Operating Procedures for recruiting, screening, and approaching potential subjects and determine eligibility according to established criteria.

• Create study Manual of Operations, Case Report Forms and Informed Consent Form documents that meet institutional guidelines and satisfy Institutional Review Board requirements.

• Work with multiple groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, Clinical Research Budgets & Billing, study sponsors) to ensure timely implementation of each research project.

• Develop and continually assess priorities to ensure that projects are executed successfully and completed within required time frames to meet research objectives.

• Develop 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. Assist in financial audits as necessary. Communicate with investigators and research staff when financial milestones have been met.

• May direct the work of student helper, research assistant or research trainee.

• Travel for protocol/study initiation meetings.Patient Management - 10%

• Coordinate clinical and research appointments, order tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Assist in monitoring patients and interacting closely with clinical providers to ensure patient safety and protocol adherence.

• Extract medical information from medical records for use on case report forms and for safety reporting requirements.

• Communicate with outside physicians who are interested in referring patients to UWMC for clinical trials.

• Obtain patient specimens (e.g., blood, urine, stool, nasal swabs, etc.) and must have good hand-eye coordination and fine dexterity to aliquot patient specimens. Coordinate and oversee processing, inventory, and shipping of study specimens. Obtain research specimens from outside providers in compliance with institution and federal regulations.Lead Responsibilities:Analyzing study data, coordinating writing manuscripts, delegating tasks to other study team members, developing timelines. MINIMUM REQUIREMENTS

• Bachelor’s Degree in Chemistry, Statistics, Biology or science related AND a minimum of 1 years experience in an academic research environment, preference will be given to candidate with prior research experience, complex statistical analysis, knowledge of FDA and NIH requirements relating to research involving human subjects, knowledge of clinical trial development, implementation and analysis, excellent written and verbal communication skills, experience with Microsoft Office/Access/PowerPoint/Excel and Adobe Acrobat.

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

• Able to work independently, self-starter, take on a leadership role whilst also being a team player; to maintain positive vision, sense of humor, and flexibility; to multi-task as priorities change, maintaining a professional demeanor at all times. Work ethic is incredibly important and prior experience in a work environment is preferred. 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.