Research Coordinator 2 - Department of Medicine, Division of Hematology & Oncology

Research Coordinator

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their Cancer Vaccine Institute team.

About this Opportunity

Reporting to the Director of Regulatory Affairs for the Cancer Vaccine Institute, the Research Coordinator 2 is responsible for promoting the research objectives of the UW Cancer Vaccine Institute (CVI) in the Division of Hematology & Oncology. The Research Coordinator 2 will play a key role in implementing clinical trials that test new cancer therapies. They will be knowledgeable and observant of all applicable rules, regulations, and guidelines for the safe and ethical conduct of clinical research.

This position works directly with clinical and laboratory-based faculty members who specialize in translational immunotherapy research targeting a variety of cancers. This position will work as a member of the Clinical Research Team that conducts primarily Phase I and Phase II Investigator-initiated clinical trials to test immune-based therapies for cancer.

The Research Coordinator works on-site at the UW Medicine at South Lake Union campus.

Key Responsibilities

Protocol Management – 60%

• Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board and study sponsors is timely, accurate and satisfies applicable regulation. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Ensure procedures 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).
• Develop, document, and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines and maintain strict confidentiality.
• Serve as subject matter and protocol expert for assigned studies. Understand research study flow, work with clinic staff, support services and research team as needed to implement clinical trials.
• Contribute to the design, creation and revision of research instruments (e.g. case report forms, Investigator Brochures, Pharmacy Manuals) as necessary to ensure quality data that satisfies research objectives.
• Seek continual improvement of work practices and participate in development of clinical protocols and consent documents. Develop informed consent documents that meet institutional guidelines and satisfy Institutional Review Board requirements
• Manage Data Safety Monitoring Plans (e.g., schedule require meetings, assist with finalizing the data reports for the Medical Monitor/Committee Members, record meeting minutes).
• Assist in preparing and conducting sponsor monitoring visits.

Site Management – 30%

• Assist external sites in implementing research protocols, as the coordinating site liaison for the CVI. Integrate research and clinical requirements to ensure patient safety and protocol compliance at our partnering site locations.
• Maintain and update all required regulatory documents and related forms per sponsor or federal requirements, ensuring individual site compliance.
• Coordinate regular meetings with the multisite staff to ensure study oversite.

Communications – 10%

• Contribute to management and updates of program/project websites, newsletters and other informational documents/products.
• Oversee development of translated Release of Information documents and other clinical consenting documents to increase patient accessibility.
• Work professionally with sponsor representatives to review and resolve data and queries recorded in the case report forms. Exercise independent judgment on query resolutions, while promoting a proactive and professional relationship with internal and external staff and affiliates.
• For investigator-initiated trials, design, document and implement audit procedures to assure protocol compliance and to ensure research data quality; develop and implement corrective action plans to ensure protocol adherence and data integrity.

Required Qualifications

To be…