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The Department of Radiology has an outstanding opportunity for a Research Nurse Coordinator (Job Profile: Research Coordinator). The Research Nurse Coordinator contributes to the growth and success of the Department of Radiology by executing the mission and vision.
The purpose of this position is to establish the support infrastructure for the Molecular Imaging Research Program at the University of Washington under the direction of the Molecular Imaging Director for the Seattle Cancer Care Alliance (SCCA)/University of Washington Medical Center (UWMC). The goal is to create a robust framework for supporting a growing number of molecular imaging and therapy clinical trials conducted predominantly at SCCA and UWMC. Therefore, this position must be able to work independently and in close collaboration with the Molecular Imaging Director as well as multiple stakeholders within Radiology, across departments, and across institutions of the University of Washington/Fred Hutchinson Cancer Research Center/Seattle Children’s Hospital/Seattle Cancer Care Alliance Cancer Consortium. Critical skills for success in this position include high level of organization and attention to detail, responsiveness to all stakeholders to accomplish needed tasks in a timely manner to meet both regulatory and funding deadlines, ability to establish workflows that enable attainment of recruitment goals for clinical studies, and resourcefulness to perform all tasks as efficiently as possible.
Essential Duties & Responsibilities (Other duties may be assigned to meet business needs.)
Protocol Development and Management:
Develops all study-related documentation required based on provided study protocols, including but not limited to consent forms, case report forms, recruitment and adverse event logs, and databases for data capture and tracking.
Creates and/or edits all correspondence and required documentation with all regulatory agencies, including institutional review boards (IRBs), Food and Drug Administration (FDA) for Investigational New Drug (IND) applications.
Assists with creation and editing of all correspondence and required documentation with funding organizations, including but not limited to governmental agencies, foundations, and industry sponsors.
Study Start-up and Management:
Works with clinical resources to establish logistics for execution of clinical research protocols, including creating standard operating procedures (SOPs) for the study procedure logistics of every clinical trial.
Creates and maintains documentation to ensure compliance with study protocols.
Captures all clinical data required for each study and maintains clinical research medical records for each subject.
Identifies occurrences of noncompliance or adverse events and creates reports in a timely fashion for required submission to regulatory agencies to meet required reporting deadlines.
Initiates and/or attends meetings required for clinical study start up and maintenance.
Evaluates clinical trial protocol logistics on an ongoing basis and meets with appropriate stakeholders regularly to ensure recruitment goals are met.
Communicates regularly with all study team members to ensure progress on clinical trials, identify issues early that hinder completion of the study, and resolve any issues that hinder completion of the study.
Tracks all reporting requirements for each trial and ensures reporting compliance by creating draft reports and reviewing with PIs prior to submission and then submitting with sufficient time to meet deadlines.
Creates organizational structure to ensure study team members have access to all updated study-related documents and reports.
Submits protocol amendments to regulatory agencies in a timely manner.
Works with referring providers to recruit and enroll study participants.
Schedules all required visits and accompanies participants to all study procedures to ensure completion.
Maintains close communication with study participants to ensure understanding of study protocol requirements and to answer any questions they may have.
Assesses clinical status of study participants during study participation and maintains close communication with study investigators, reporting any changes in clinical status in a timely manner to investigators for review and reporting, if needed.
Completes radiation safety training and is willing to assist nuclear medicine technologists as needed in carrying out study procedures related to the administration of radiopharmaceuticals.
Analysis and Reporting:
Extracts and summarizes data from clinical and clinical research medical charts as needed for reporting requirements for each clinical trial, including reports to regulatory agencies, funding agencies.
Extracts and formats data collected from clinical trials for analysis for publication.
Assists with data display for publication.
Tracks all study procedures completed, expected costs to the clinical trial as a result of completed procedures, and reconciles research bills and invoices with completed procedures.
Creates budgets for imaging clinical trials and meets any associated deadlines for these budgets.
Participates in all meetings needed to ensure accurate budget creation and accounting for clinical trials.
Bachelor’s in nursing or higher. At least 4 years of clinical experience.
Excellent verbal and written communication skills.
Ability to work independently.
Working knowledge of Word and Excel.
Ability to maintain high level of attention to detail, maintain meticulous records, organize large amounts of data and files, and track submissions.
Willingness to learn how to safely handle radiopharmaceuticals and/or radioactive materials and handle radiopharmaceuticals/ radioactive materials in compliance with regulations.
Ability and motivation to learn any new skills required to support new projects.
Equivalent education and/or experience may substitute for minimum requirements.
Experience with radiopharmaceutical studies preferred.
Experience with any or all clinical research studies, including regulatory processes related to IRB, FDA, and/or RDRC, study protocol design and execution, subject monitoring, clinical research charting.
Experience in extracting and summarizing data for analysis.
Experience with data handling software and databases.
MISSION AND VALUES
Mission: To meet the clinical needs of patients and families we serve, to train the practitioners and leaders of tomorrow, and to advance imaging sciences to improve the human condition.
Innovation & Impact
CONDITIONS OF EMPLOYMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to sit; stand; walk; use hands to write, finger, handle or feel; and reach with hands and arms. The employee must occasionally lift and/or carry up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
Schedule is normally 8a to 5p, M-F, but is not always fixed and workload does vary. The incumbent¹s first responsibility is to complete tasks rather than keep to a fixed schedule. Flexibility in schedule and intensity of work is necessary.
Some travel between sites will be necessary by UW Health Services or other shuttles.
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.