The University of Washington is seeking a full-time Research Coordinator to promote the research objectives of the Hematology Clinical Research Program. This role involves implementing and coordinating multiple clinical trials while ensuring compliance with regulations and managing study subjects.
Responsibilities
- Implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Food and 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)
- Use knowledge of clinical research, medical terminology, and clinical processes to interpret standard protocol requirements and identify protocol procedures that will impact clinic operations
- Design, develop, document, and maintain policies and procedures for protocol registration and 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 correlates with research objectives
- Design, document, and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality
- Work with research team to ensure that projects are executed successfully and completed within required time frames to meet research objectives
- Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract research organizations, and Institutional Review Board
- Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board and study sponsors are timely, accurate, and satisfy applicable regulation. Work with research team on developing and implementing corrective action plans to ensure protocol adherence and data integrity
- 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
- Communicate with investigators and research staff when financial milestones have been met
- Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol)
- Take action to correct problems such as deviation from protocol requirements to ensure research quality
- Ensure that projects are executed successfully and completed within needed time frames to meet research objectives
- Prepare laboratory and specimen collection kits according to protocol and lab manual instructions. Work with different departments across UW and FHCC to collect, process, and transport specimen samples
- Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data
- Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers
- Initiate and maintain communication with outside physicians who refer patients to UWMC and/or FHCC for clinical trials
- Timely and appropriate reporting of Adverse Events and Serious Adverse Events to sponsors and review boards to ensure compliance to protocol and FDA requirements
- Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion
Skills
- 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
- Strong attention to detail and ability to multi-task, organize, and prioritize projects and competing deadlines
- Excellent written and verbal communication skills
- Strong computer skills and competency with Microsoft Office software
- 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 30 days of hire
- Previous experience working in Hematology and/or Oncology
- Previous experience working in clinical research with human subjects
- Experience working within the UW/FHCC setting
- Familiarity with Epic
Benefits
- For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Company Overview
University of Washington is an educational institution that provides undergraduate, graduate, and research programs. It was founded in 1861, and is headquartered in Seattle, Washington, USA, with a workforce of 10001+ employees. Its website is http://www.washington.edu.Company H1B Sponsorship
University of Washington has a track record of offering H1B sponsorships, with 249 in 2025, 211 in 2024, 159 in 2023, 171 in 2022, 169 in 2021, 154 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Apply Now