Job Description

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 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 minimum 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.

• Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Preferred 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.

• Previous experience conducting research in a hospital or academic setting

• Knowledge of UW and/or FHCC policies, systems and procedures

• Experience in an academic or non-profit research environment

• Previous experience working with oncology patients

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.

About the Team

The University of Washington's Division of Hematology & Oncology includes 200+ staff members and 450+ faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center (FHCC), and the VA Puget Sound Health Care System. As the premier hematology/oncology program in the Pacific Northwest, we balance the twin aims of innovative, life-saving research and knowledge-driven, patient-focused cancer care. 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

Pay Range Minimum:

$67,200.00 annual

Pay Range Maximum:

$84,000.00 annual

Other Compensation:

-

Benefits:

For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/

Shift:

First Shift (United States of America)

Temporary or Regular?

This is a regular position

FTE (Full-Time Equivalent):

100.00%

Union/Bargaining Unit:

UAW Research

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.