|Req #: ||145188 |
|Department: ||ALLERGY AND INFECTIOUS DISEASES |
|Job Location: || South Lake Union |
|Job Location Detail: ||SLU E610 |
|Posting Date: ||05/17/2017 |
|Closing Info: || Open Until Filled |
|Salary: ||Salary is commensurate with experience and education |
| The University of Washington (UW) is proud to be one of the nation's premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty. |
The Division of Allergy and Infectious Diseases at the University of Washington has long been prominent nationally and internationally. Through support provided by NIH-sponsored training grants, the Division has one of the largest and most well-known postdoctoral training programs in the United States.
The Division of Allergy and Infectious Diseases in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator. The Research Coordinator will serve as the assistant to the Director (PI) to manage all phases of a large multi-site, Gates Foundation funded Human Clinical Trial focusing on the impact of Clofazamine given to a population compromised by Cryptosporium infection with possible tuberculosis and HIV complications. The investigators for this project are distributed over 2 sites within the US and two internationl sites in the UK and Africa. and the management and communication of data will be a major responsibility of this position. The Research Coordinator will need to interpret data on project issues and make good decisions with support from experienced team members on study management. The Research Coordinator will ensure clinical activity is conducted within contract scope, through efficient management of the clinical team, and adhere to timelines established for trial success and to assume ownership of all project data analysis.
Duties & Responsibilities:
Research Study Management
Manage all clinical operations and quality of studies. Help develop and implement research project policies and procedures that meet research objectives and ensure human subjects compliance.
Participate in design and development of CRFs, CRF guidelines, patient informed consent templates, etc. Monitors clinical activity timelines and metrics.
Implement data collection and storage procedures that ensure HIPPA compliance.
Take action to ensure research is progressing according to proposed budget.
Design and implement a project calendar/timeline that envelopes all administrative , financial, and operational components of the project, and ensure work is completed on time to meet research objectives.
Collaborate with research faculty to provide data/financial information for grant and manuscript preparation.
Lead regular meetings with key study personnel and provide up-to-date status.
Research Data Management
Oversee research data collection from appointed staff and take action to correct any problems or deviations from established protocols. Initial data collection will occur in Malawi Hospital and require the Research Coordinator to strategize and implement the most effective form of extraction that will not negatively impact patients or health care providers. Implement data collection forms and research-related testing.
Develop and implement data archival system for research study records to ensure careful, succinct documentation of research study actions made by the team and ensure HIppa compliance. Will act as primary contact for auditing purposes.
Provide management and leadership to the research and clincal staff. Act as primary off-site manager to address deviations from protocols and develop/implement corrective actions.
Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
Responsible for set up, organization, content and quality of the relevant sections of the Trial Master File.
Participate in design and development of CRFs, CRF guidelines, patient informed consent templates, etc.
Monitors clinical activity timelines and metrics. Implement data collection and storage procedures that ensure HIPPA compliance.
Data analysis and dissemination
Organize and present at meetings, conference calls.
Accountable for achieving the final clinical deliverable within the time period specified in the contract with the funder. Interpret data on project issues and make good decisions with support from experienced team members or study management.
Ensure clinical activity is conducted within contract scope, through efficient management of the clinical team under human trial regulations.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
| Bachelor's degree plus a minimum of 3 years of clinical operations experience, with increasing levels of responsibility. preferred to have clinical trials program management experience in Academia, Pharmaceutical, Biotechnology, Medical Device and/or CRO industry. |
Must have prior experience managing a clinical trial portfolio or large scale clinical trial program globally and be able to demonstrate a proven track record of successfully leading cross-functional projects in a global environment.
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH/Good Clinical Practices regarding drug development phases, clinical research and data management methods.
Therapeutic experience in infectious diseases preferred
Experience in early phase trials (Phase I-II) and First-In-Man trials is preferred
Ability to travel domestically and internationally is required.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
| Master's or PhD preferred |
Knowledge, Skills and Abilities:
Read, write and speak fluent English; excellent verbal and written communication skills.
Prior line management experience is desirable.
Prior monitoring and clinical project management experience is desirable
|CONDITION OF EMPLOYMENT:|
| Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check. |
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 Workforce Authorization, Criminal Conviction History, 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.