Details
Posted: 21-Jan-23
Location: Seattle, Washington
Type: Full Time
Salary: Open
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 Ophthalmology has an outstanding opportunity for a Research Coordinator to join their team.
POSITION PURPOSE The ability to understand and affect the course of complex, multi-system diseases such as type 2 diabetes has been limited by a lack of well designed, high quality, large, and inclusive multimodal datasets. This Bridge2AI project seeks to create such a dataset allowing machine learning approaches to provide critical insights into the endemic condition, type 2 diabetes mellitus (DT2). The project will collect a cross-sectional dataset of more than 4,000 people across the US with dual balancing for self-reported race/ethnicity and four stages of diabetes severity.
This position is responsible for coordinating an ongoing portfolio of research projects in the Lee Computational Ophthalmology Lab. This includes project startup such as budgeting and regulatory activities, along with implementation of study protocol and close out actions, all while adhering to university and sponsor guidelines.
In addition, the individual in this position will work with the Offices of Human Subjects, Compliance, Sponsored Projects, and others as necessary to get all the required approvals prior to submission. The incumbent will also assist in preparing reports to the funding agencies and serve as liaison to external vendors and perform other related duties as needed. Under the supervision of the principal investigators and the research manager, the incumbent will follow research protocols to obtain data through interviewing subjects/patients, conducting on-site assessments, operating ophthalmic imaging equipment, consulting with the physician and reviewing medical records, coordinating patient participation in ophthalmology studies and compile and verify the accuracy of research data.
DUTIES AND RESPONSIBILITIES Research Study Management: 50% Serve as the point-person for tracking tasks and documents between UW and all collaborative sites (e.g. SOPs, enrollment, site challenges) and provide reports to faculty leadership on a weekly basis. Responsible for study start-ups to include assisting with feasibility questionnaires, communications with study sponsors, completion of study sponsor forms, development, submission and revisions of informed consent forms (ICFs), working with Zipline for IRB submissions, submission of any necessary protocol modifications to the IRB and/or WIRB, work with CRBB for study start-up and ongoing study conduct, conduct submissions to WIRB, submissions to DSMBs, development and maintenance of SOPs for study protocols. Ensure that projects are executed successfully and completed within needed timeframes to meet research objective. Coordinate specialized tasks with the medical team such as venipuncture and operation of electronic monitoring equipment, processing of laboratory specimens, administering of treatment and/or medication in accordance with research protocol, assessment of patient reaction to medications and/or treatments as part of a research protocol and identification of potential adverse reactions. Perform certain non-invasive patient-oriented procedures. Responsible for the collection, processing and shipping of study-specific laboratory specimens. Coordinate physician examinations and study protocol for technicians. Review medical records. Keep study files in compliance with regulatory requirements. Read, interpret, and communicate protocol for clinical studies. Establish and maintain effective working relationships with patients and their families, professional or community groups and volunteers. Communicate with the Departmental Administrator regarding the entire portfolio of clinical trials including workflow, timelines, funding and other pertinent information. Ensure research trials and projects meet regulatory requirements and are compliant with federal and institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution, and patient safety. This position may work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA, sponsor, etc.). Oversee, coordinate, and implement regulatory submissions to internal and external governing bodies.This includes new study applications, annual reviews, modifications to existing studies, serious adverse events, and protocol deviations.
Patient/Participant Management: 25% Develop and implement procedures and policies to carry out clinical research studies involving human subjects including data collection methods and strategies for data management. Screen, recruit and interview potential subjects to determine eligibility according to specific study protocols. Obtain informed consent. Enroll patients in research protocol. Explain research protocols to participants. Respond to patient inquiries regarding protocol. Schedule patient participation. Ensure compliance with research protocol. Inform referring physicians of protocol requirements, as appropriate.
Research Data and Publication Management: 15% Maintain records and computer databases of study data. Design & update data collection tools. Obtain and record research data in conjunction with physician and other professionals on the research team. Manage electronic transfer of data. Prepare interim reports for Principal Investigators, Study Sponsor and Human Subjects Review Board to Ensure that each project timeline is being met. Communicate with pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms)
Other Duties as Assigned: 10%
MINIMUM REQUIREMENTS Bachelor's Degree in health management, biological/social sciences, social work or related fields. 2 years working on research projects involving human subjects. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS Proficient in Microsoft Office applications. Experience with or familiarity with data entry into databases (ex: REDCap). Strong attention to detail and ability to multi task, organize and prioritize multiple projects. Ability to work independently and in a group under limited direction. Excellent verbal, written, interpersonal and communication skills. Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
DESIRED QUALIFICATIONS Prior experience with human subjects research preferably in an academic or healthcare-related setting, and preferably in health services and outcomes projects. Background working in ophthalmology or eye clinics. Candidates of non-traditional educational or experiential backgrounds are encouraged to apply. Experience recruiting & consenting by telephone. Experience conducting participant outreach and data collection by telephone. Experience with community recruitment for research studies. Training and/or knowledge in ethical conduct of research with human subjects. Experience with the UW grant approval process.
CONDITIONS OF EMPLOYMENT Must pass WA state patrol background check
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 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. |