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Research Coordinator - Seattle, United States - University of Washington
Description
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 Department of Neurology has an outstanding opportunity for a 100% FTE Grade 6 RESEARCH COORDINATOR. This position is responsible for coordinating ongoing clinical trials within the Memory and Brain Wellness Center.
This includes project start-up such as regulatory activities, along with the implementation of study protocols and close-out actions, all while adhering to University and sponsor guidelines.
DUTIES AND RESPONSIBILITIES
Research Study Management 35%
Serve as the point-person for tracking tasks and documents between UW and all collaborative sites (e.g. SOPs, enrollment, site challenges) and provide updates to the program manager on a weekly basis.
Responsible for study start-ups to include communications with study sponsors, submission and revisions of informed consent forms (ICFs), working with Zipline for IRB submissions, submission of any necessary protocol modifications to the WIRB, work with CTO for ongoing study conduct, conduct submissions to WIRB, and maintenance of SOPs for study protocols.
Independently execute 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 subject reaction to medications and/or treatments as part of a research protocol and identification of potential adverse reactions.
Responsible for the 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 Food and Drug Administration's regulations;
Read, interpret and communicate protocol for clinical studies providing data on the safety and efficacy of new drugs;
Establish and maintain effective working relationships with subjects and their families, professional or community groups and volunteers;
Maintain contact with public agencies which are involved with aspects of the research of general public health care;
Manage, coordinate, and implement regulatory submissions to internal and external governing bodies. This includes annual reviews, modifications to existing studies, serious adverse events, and protocol deviations.
Patient/Subject Management 40%
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 the specific study protocol.
Obtain informed consent;
Enroll subjects in research protocol;
Explain research protocol to subjects;
Respond to subject inquiries regarding protocol;
Schedule subject participation;
Coordinate all aspects of the subject's care;
Ensure compliance with research protocol;
Inform referring physicians of protocol requirements;
Research Data Management 15%
Manage and update records and computer databases of study data;
Design data collection tools;
Obtain and record research data in conjunction with physicians 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, Biology, Nursing, Psychology, or other related fields.
One year of experience required.
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 research coordination
Proficient in Microsoft Office applications
Experience with UW Epic and REDCap data entry
Experience in subject interviews
Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
Ability to work independently and in a group
Excellent verbal, written, interpersonal, and communication skills
Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities
DESIRED QUALIFICATIONS
Fluent Spanish speaking
Experience with the UW CTMS and clinical trials process.
Experience communicating with industry sponsors regarding study processes and monitoring.
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.
