University of Washington Jobs

Req #: 235463

Department: DEPARTMENT OF MEDICINE: ALLERGY & ID

Posting Date: 06/13/2024

Closing Info: Open Until Filled

Salary: 50% of $5,696 - $8,300 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/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230119_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.

Department of Medicine: Allergy and Infectious Diseases has an outstanding opportunity for Part Time Research Coordinator. Position Purpose: The UW Division of Allergy and Infectious Diseases (DAID) has an outstanding opportunity for a part-time Research Coordinator. This Seattle-based position will coordinate a research portfolio of multiple studies, most based in Kenya, including sponsored clinical trials of drugs and vaccines, translational research, epidemiological studies, and implementation research. We are seeking an experienced and effective coordinator who is excited about the opportunity to take a leadership role in a fast-paced, complex, and highly productive international collaborative research program.

Position Complexities: As a Research Coordinator, you will take a leadership role in duties of a complex, multidisciplinary, international research portfolio. You will work closely with the Principal Investigator, sponsors, collaborating institutions and investigators, trainees, and research and administrative staff in the US and Kenya. You will be responsible for study management, regulatory compliance, general research support, and financial management. You will have primary responsibility for leading a team in meeting deadlines and research objectives including site assessment documents, reports, clinical trial agreements, ethics and regulatory submissions, database preparation, and study launch. The Research Coordinator must be someone who will thrive in a collaborative work environment and is capable of working on multiple projects concurrently.

Position Dimensions and Impact to the University: The University of Washington is committed to multidisciplinary research that contributes to the prevention and treatment of infectious diseases including, but not limited to, HIV, sexually transmitted infections, tuberculosis, and SARS-CoV-2. The research group, part of the Department of Medicine, Division of Allergy and Infectious Disease, conducts research in Kenya and the United States, conducts a wide range of research including clinical trials, translational research, epidemiological studies, and implementation research. Research in Kenya is conducted in close collaboration with local partner institutions including Kenyatta National Hospital, the University of Nairobi, the Kenya Medical Research Institute, and local health authorities at the national and county levels. Operations are supported by the Pwani Research Centre, a collaborative research site of the University of Washington and the University of Nairobi, and by the UW-Kenya non-governmental organization. This position will be responsible for representing the research group to external groups, assisting with the planning and implementation of research in Kenya and the US, and will make a significant contribution to meeting project goals and adding to the growing field of infectious disease research.

RESPONSIBILITIES: Study Management 40%

• Oversee start-up, implementation, and close out of research protocols • Lead development and implementation of a quality management plan for non-VTEU clinical trials • Work with partners to ensure all protocol requirements are met • Work with investigators and study teams in the US and in Kenya to implement studies • Works with the PIs and study teams to resolve issues as they arise

Regulatory compliance (Non-VTEU studies, particularly clinical trials) 30%

• Develop and write study protocols, DSMB charters, safety and reporting plans • Draft consent forms, study instruments, and data collection forms. • Maintain study regulatory databases such as CT.gov • Orchestrate submissions of documents to the FDA for IND applications • Coordinate MTAs • Act as a primary liaison between investigators, sponsors, and federal agencies regarding study conduct and regulatory compliance • Serve as a resource with collaborating researchers from both internal and external entities and institutions • Oversee industry, federal, and institutional audits pertaining to regulatory compliance • Prepare IRB applications for UW and Kenyan IRBs • Prepare IRB modifications and renewals for UW and Kenyan IRBs

General research support 20%

• Systematic literature review and summary • Support preparation of grant applications including drafting some sections of grant proposals • Preparation of grant progress reports • Prepare presentations of research data • Data visualizations • Draft parts of manuscripts – opportunity to first author some manuscripts if desired • Set up data entry platforms for new studies; REDCap, SPSS, MS Access • Work remotely and in person with research teams in Kenya in trainings, study support, preparation of reports, regulatory submissions.

Financial Management 10%

• Participate in budget preparation including helping to determine staff effort on study by study basis. -this would include both preparation of budgets for new grant applications and working with sponsors to negotiate budgets for sponsored studies • Review clinical contract agreements and track agreements through UW sign off. • Work with fiscal staff in the ID Division, at the Pwani Research Centre, and at UW-Kenya to ensure compliance with sponsor and UW policies and maintenance of accurate fiscal reports and projections • Review and approve expenditures

MINIMUM REQUIREMENTS:

Bachelor's Degree in a Science or a related field. Equivalent experience can substitute for degree requirement. At least three years of experience to including:

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

• Experience in clinical research management in a research setting or an equivalent combination of education and experience. Thorough knowledge of IRB, HIPAA, HSP, GCP and FDA regulatory requirements for the conduct of research.

DESIRED:

• Excellent written and verbal communication skills, organizational skills, and interpersonal skills • Ability to work independently, and to provide leadership in a team setting - previous experience in a clinical research setting. • Must demonstrate a strong attention to detail • Previous computer experience including database management and/or development, using Word, Excel, PowerPoint, Endnote, Adobe Illustrator, Access, and REDCap • Ability to prioritize competing demands to successfully meet deadlines and project milestones • Must have at least two years of experience with clinical trials (drug, vaccine, or device) • Experience with protocol development and clinical monitoring procedures required • Master’s degree in Epidemiology, Public Health, or Global Health is highly desired • Demonstrated experience in working through the development, implementation, and closeout phases of research projects • Prior staff training and leadership experience. Ability to work independently • Previous experience in international collaborative health-related research • Experience with IRB applications, modifications, close-out procedures

WORKING CONDITIONS:

• Requires travel to Kenya two to four times per year – 2-4 weeks total – to work with study teams and collaborating partners.

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.

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.