Research Coordinator 1

University of Washington•Seattle, WA

About The Position

The Department of Neurology has an outstanding opportunity for 100% FTE Research Coordinator 1. About This Opportunity Reporting to the Principal Investigator the Research Coordinator will be responsible for the coordination and implementation of research projects that focus on the understanding, treatment, and outcomes of stroke. This individual will develop and review research tools and protocols, maintain IRB approvals and consent forms, and participate in data collection and data management for NIH and industry sponsored projects. Additional duties may include, but are not limited to, coordinating multiple data collection efforts with other institutions, designing the phases of the research projects, recruiting and overseeing recruitment of human subjects, writing and editing reports, data management, and preparing conference presentations and manuscripts for publication. This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This individual will develop procedures that ensure that all research meets or exceeds these requirements. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the research objectives. This individual is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. They will also be responsible for maintaining communication with researchers at other universities. The individual in this position will aid in furthering the academic pursuit of the UW by contributing their time and knowledge base to our research studies.

Requirements

Bachelor’s degree in a related field and one year of relevant experience. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration. Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.
Knowledge and prior experience with human subject’s institutional review process including developing protocols and working with the IRB for approvals.
Strong writing skills including a demonstrated ability to write for publication in peer-reviewed scientific journals.
Strong project management skills.
Background and experience conducting research projects that met programmatic and regulatory requirements.
Training and/or knowledge in ethical conduct of research with human subjects.
Ability to work as a collaborative, cooperative, and congenial member of a close knit scholarly and administrative team, as well as work independently.

Nice To Haves

Certifications in Health Information Portability and Accountability Act and Human Subject Research.

Responsibilities

Patient Management - 50%
Identify, consent, enroll and follow up patients in clinical trials.
Assist in scheduling appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.
Assist in monitoring and administering patient protocol, interacting closely with clinical providers to ensure patient safety and protocol adherence.
Communicate with outside physicians who are interested in referring patients to UWMC/HMC for clinical trials in stroke.
Understand clinical trial budget and billing plan for patients enrolled on clinical trials.
Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance.
Assist in financial audits as necessary.
Communicate with investigators and research staff when financial milestones have been met.
Protocol Management - 40%
Develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
Design, create, revise, and complete research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.
Design, develop, document and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives.
Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality.
Develop and implement corrective action plans to ensure protocol adherence and data integrity.
Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Analysis and Reporting - 10%
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.
Assist in analyzing data to be presented at conferences or published in scientific journals.
Assist in financial audits and communicate with research investigators when financial milestones have been met.
Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.
Other duties as assigned.