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Job Description

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

About this Opportunity

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).

Key Responsibilities

Patient Management - 40%

• 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 includingoutside 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.

Protocol Management - 30%

• 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.

Data Management - 30%

• 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.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Minimum Qualifications

Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager

• Bachelor's degree in science or a health-related field and two years of clinical research work experience.

Additional Qualifications

• Excellent written and verbal communication skills
• Organizational skills and attention to detail
• Ability to work well independently and as a member of a team

Preferred Qualifications

• 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

Working Conditions

• The Cancer Vaccine Institute is located at the UW Medicine at South Lake Union campus in a translational research environment that includes laboratory, clinical research and administrative office areas. This position requires some off-site travel to University of Washington Medical Center, Fred Hutch Cancer Center, and Bloodworks Northwest.A shuttle is available.
• Work is typically deadline driven and requires a high level of accuracy, extensive communication with staff and external collaborators from diverse backgrounds.
• This position may require a flexible work schedule.
• Stringent deadlines for protocol implementation, data collection, integrating required elements of research into complex patient schedules, and special event coordination may require occasional evening or weekend work.
• 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.
• Patients currently being enrolled in CVI trials typically have advanced stage cancer, and the emotional impact of working closely with this patient population can be a challenge.
• This position must be able to work independently on multiple research projects with minimal written policies and procedures. This requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.

About the Team

The University of Washington's Division of Hematology & Oncology includes 200+ staff and 130+ faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center (FHCC), and the VA Puget Sound Health Care System. Over the past 40 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.

Compensation, Benefits and Position Details

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About the UW

Working at the University of Washington provides a unique opportunity to change lives - on our campuses, in our state and around the world.

UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu.

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.