Req #: 238463 Department: DEPARTMENT OF MEDICINE: ALLERGY & ID Appointing Department Web Address: https://www.chulab.org Posting Date: 09/10/2024 Closing Info: Open Until Filled Salary: $6,339 - $7,900 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** The Division of Allergy and Infectious Diseases has an outstanding position for **Program Operations Specialist.** The Chu Lab is involved in several clinical research studies focused on SARS-CoV-2 (COVID-19) and other infectious respiratory pathogens and is seeking a Research Project Director to lead a multi-year CDC-funded study of population-level SARS-CoV-2 vaccine effectiveness. Under the general supervision of the Principal Investigator, the Program Operations Specialist will work with the Principal Investigator and a multi-disciplinary team of researchers and research staff in planning and coordinating daily activities to achieve the overarching objectives and specific aims of the SEAPrep study. **POSITION COMPLEXITIES** This position is one of high responsibility, providing lead support and high-level professional operational and technical coordination of a large complex research study. The position requires interacting with people across multiple healthcare and research sites, including with participants, team members, community members and funding agency representatives. The person will need to have strengths in multi-institution network management, remote and in person meeting management, data-use agreement coordination, experience working with multiple UW offices and groups such as HSD, OSP, ITHS, and REDCap. Knowledge of IRB, local, and national regulations related to the conduct of research studies is an additional asset. **POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY** The University of Washington is committed to research that utilizes epidemiologic studies to further general understanding and knowledge surrounding incidence, prevalence, risk factors and prevention of infectious diseases including influenza and SARS-CoV-2. The Chu Lab, part of the Department of Medicine, Division of Allergy and Infectious Diseases, has a history of running multiple large scale studies that have contributed greatly to repertoire on RSV/influenza and, more recently, SARS-CoV-2 research. This position will be participant facing and will include interactions with University of Washington clinicians as well as external collaborating groups, and will make a significant contribution to meeting project goals and adding to the growing field of infectious disease research. The purpose of the position is to assist?with?the development, oversight, and execution of investigator-driven clinical research studies. The position will be directly supervised by the Program Manager with minimal supervision in performing assignments. This position will?work closely with?other Research Coordinators, Regulatory Coordinators, collaborators and study stakeholders?to execute this research program. **DUTIES AND RESPONSIBILITIES** The Program Operations Specialist will be responsible for directing the day-to-day project management activities across the large complex study to ensure project goals and timelines are met, quality data is collected and managed, and to assure participant and/or data confidentiality. Responsibilities include but are not limited to: Project Management (70%) + Oversee the start-up, implementation and close-out of study-specific research protocols and work with process partners to ensure all protocol requirements are met + Oversee the development of research project timeline, procedures, forms, scripts, manuals, and tracking systems + Supervises the regulatory and compliance aspects of the study, including overall oversight of human subjects submissions, protocol development, and data management + Lead implementation of study protocol and determine most efficient clinic processes and identifies areas of best practice and recommend process improvements + Monitors and allocates resources to ensure clinic is staffed to meet study goals + Conducts weekly staff meetings to provide a forum to communicate study progress, updates and questions + Identify delays and deviations and accordingly revise work plan to ensure timely completion + Responsible for progress reports to the sponsor + Manage study finances including creation and tracking of study budgets, spending, and reimbursementsStaff Management (20%) + Train & orient new staff - online trainings, lab background readings, badge and key, orientation overview to study + Maintain job duty and roles and responsibilities documents for each staff member + Conduct annual performance reviews for staff + Write job descriptions, conduct phone screenings and in person interviews for new staff positions; assist PI with salary negotiation and finalizing hires + Train clinical personnel in protocol implementation + Coach, develop and mentor staff/team members + Partner with PI to create staffing plansRegulatory Compliance Activities (10%) + Act as primary liaison between investigators, sponsors, and federal agencies regarding study conduct and regulatory compliance + Develop and write study protocols, SOPs and Safety and Reporting plans + Draft consent forms, study instruments, and data collection forms for this study + Coordinate Material and Data Transfer Agreements + Serve as a resource with collaborating researchers from both internal and external entities/institutions + Serve as a critical resource to investigators for regulatory matters and the implementation of policies and procedures in clinical research studies + Support CHR in quarterly reports (Development, editing, dissemination) **MINIMUM REQUIREMENTS** + Bachelor's Degree in health services, medical or public field or a related field. Equivalent experience can substitute for degree requirement. At least three years of experience. **Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.** **ADDITIONAL REQUIREMENTS** + Experience with research administrative and management. + Extensive working experience with observational and clinical phase 1-4 clinical trials, particularly in vulnerable populations such as pregnant women and children. + Extensive research experience in social, behavioral, health services, clinical, or related areas. + Research experience within an operating health care system. + Working knowledge of medicine, public health, and health services issues relevant to the application of research to health care and health care policy. + Through knowledge of standard desktop computing software packages (word processing, spread sheeting, presentation software, Internet browsers, etc.). + Thorough knowledge of specialized models and theories in a discipline area applicable to the research. + Some training in management or administration and supervision. + Excellent organizational, writing, communication, and supervisory skills. + Excellent word processing, spread sheeting, and Internet skills. + Excellent computer programming skills. **DESIRED QUALIFICATIONS** + Thorough knowledge and ability to interpret and lead submissions to IRB. Able to implement study following HIPAA, GCP and FDA regulatory requirements for the conduct of clinical research. + Working experience with conduct and supervision of observational and clinical phase 1-4 clinical trials. + Considerable experience in the application of word processing, spread sheeting, Internet Browsers, statistical software packages and database management software to research activities. + Working knowledge of standard desktop computing software packages (word processing, spread sheeting, Internet browsers). + Thorough knowledge of statistical theory and hypothesis testing, quantitative or qualitative analysis methods, and database management techniques relevant to the design, conduct, and analysis of research projects in the pertinent substantive area. + Working knowledge of medical and health care issues sufficient to communicate effectively and to collaborate with investigators in the conduct of research. + Working knowledge of specialized models and theories in a discipline area applicable to the research. + Excellent writing and communications skills. + High level of computer operations skills, including word processing, spread sheeting, presentation software, and Internet browsers. + Excellent organizational and supervisory skills to carry out research activities under the general direction of an investigator. **CONDITITONS OF EMPLOYMENT** The ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.There may be meetings or appointments over which an individual has no control that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs. This position is located in a clinical and research environment that is located at South Lake Union UW campus and the Research Coordinator will have a designated workspace. **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.\#UWDeptMedicineJobs 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.