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

University of Washington Medical Center•Seattle, WA

1d•$69,600 - $84,000•Hybrid

About The Position

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their Cancer Vaccine Institute (CVI) team. Reporting to the Research Coordinator 3 at the Cancer Vaccine Institute (CVI), the Research Coordinator 2 is responsible for promoting the research objectives of the UW 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 under moderate supervision 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, and also, requires some off-site travel to University of Washington Medical Center, Fred Hutch Cancer Center, and Bloodworks Northwest (for which a free UW shuttle is available).

Requirements

Bachelor’s degree in science or a health-related field and two years of clinical research work experience.
Excellent written and verbal communication skills
Organizational skills and attention to detail
Ability to work well independently and as a member of a team

Nice To Haves

Experience with Microsoft Office, Smartsheet
Previous experience working with oncology patients
Previous experience conducting research in a hospital or academic setting
Extensive knowledge of UW and/or FHCC policies, systems and procedures
Experience in an academic or non-profit research environment

Responsibilities

Implement research protocols at UWMC and FHCC, integrating research and clinical requirements to ensure patient safety and protocol compliance, maintaining strict confidentiality.
Communicate research requirements effectively with all providers involved in patient care including outside physicians who are interested in referring patients to CVI for clinical trials.
Promote a proactive and professional relationship with internal and external staff and affiliates.
Screen, recruit and interview potential subjects to determine eligibility.
Explain logistical, clinical, and scientific aspects of clinical trials to potential study participants by telephone, e-mail, and/or in written documents.
Communicate with cancer patients effectively and with empathy.
Coordinate and assist with patients visits in collaboration with CVI clinical research staff and providers.
Schedule, track and maintain research subject schedules based on complex protocol-specific requirements.
Align research requirements and clinical care to ensure collection of accurate and reliable data.
Assist in ensuring patient safety while participating on a clinical trial by monitoring patients and interacting closely with the patient's clinical providers.
Independently obtain patient medical records and develop a preliminary assessment of patient eligibility for Principal Investigator approval.
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.
Serve as subject matter and protocol expert for assigned studies.
Contribute to the design, creation and revision of research instruments (e.g. case report forms, AE logs, Study guides) 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.
Create and maintain complete source documentation for patients on assigned studies.
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.
Manage minimal risk protocols, including consenting patients for sample collection.
Retrieve data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into internal and sponsor provided case report forms/database.
Case report form may be paper based or electronic.
CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members.
Prepare source data documents to collect/support all data associated with research protocols.
Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.
Code and record said information into various study-specific data-capture systems (both electronic and paper-based).
Maintain computer spreadsheets and databases for research studies.
Design and revise data management tools to ensure quality data that satisfies research objectives
Work professionally with sponsor representatives to review and resolve data and queries recorded in the case report forms.
Exercise independent judgment on query resolutions.
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.