Research Coordinator 2

University of Washington•Seattle, WA

5d•Onsite

About The Position

The Department of Neurology has an outstanding opportunity for 100% FTE Research Coordinator 2. Reporting to the Principal Investigator, the Research Coordinator will be responsible for the coordination and implementation of support research focused on neurodegenerative diseases, including Huntington’s disease, Parkinson’s disease, and ataxias. This individual will maintain IRB approvals and consent forms, participate in data collection and data management for federal and industry sponsored projects. 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. 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 foundation-initiated audits of study data. 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 two years 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.
Knowledge and prior experience with human subject’s institutional review process including developing protocols and working with the IRB for approvals.
Experience in clinical trial processes and implementation of research protocols
Demonstrated ability to work independently with minimal supervision
Training and/or knowledge in ethical conduct of research with human subjects.
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire.

Nice To Haves

Sound knowledge of IRB submission procedures, FDA, GCP, and NIH requirements relating to research involving human subjects
Certified Clinical Research Professional (CCRP) certification

Responsibilities

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
Design, create, revise, and complete research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with 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.
Maintain regulatory documents in accordance with local and federal requirements.
Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Recruit, screen, 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.
Coordinate all aspects of subjects’ participation including but limited to: scheduling appointments, ensuring ordering of tests and procedures, billing compliance.
Implementing 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 research.
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 and budget.
Maintain records of study data.
Communicate with Principal Investigators, pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms).
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.
Perform other duties as required
Other duties as assigned