Clinical Research Program Manager Jobs in Everett, WA

Job Description
The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their Hematologic Malignancies Research team.
About this Opportunity
Reporting to a Senior Research Coordinator 3 and under the leadership of the Clinical Research Program Manager, the Research Coordinator 2 is responsible for promoting the research objectives of the UW Hematologic Malignancies Research Program in the Division of Hematology and Oncology. The Research Coordinator 2 is an intermediate level professional research coordinator and will play a key role in developing and implementing procedures for clinical trials that test new treatment 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 under moderate supervision as a member of the Clinical Research Team and works directly with clinical and laboratory-based faculty members who specialize in research targeting a variety of blood disorders, blood cancer, and rare diseases.
The Research Coordinator works on-site at the Fred Hutchinson Cancer Center (FHCC), and occasionally at the UW Medical Center, and may be eligible to be considered for a hybrid telework schedule.
Key Responsibilities
This position must be able to work independently under administrative direction on multiple clinical trials without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, providers, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. This position will manage multiple clinical trials, including out-patient and in-patient elements, with the expectation of additional projects in the future.
Protocol, Patient, and Data Management - 85%

• Collaborate to develop and implement research project policies and procedures that meet research objectives and that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects.
• Design, develop, document and maintain policies and procedures for protocol implementation to ensure research execution meets good clinical proactive guidelines.
• Design, create, revise, and complete research instruments (e.g. protocol visit checklists, and subject trackers) as necessary to ensure quality data that correlates with research objectives.
• Assist with implementing procedures for protocol audits to assure protocol compliance and research data quality.
• Take action to correct problems such as deviations from protocol requirements to ensure research quality. Assist with creating and implementing CAPA plans.
• Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
• May process labs for clinical trials, including centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.
• Ensure protocol compliance by managing patient appointments, including proposing research specific orders within the EMR, and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
• Support and ensure complete protocol compliance and data collection in clinic. This includes collection of adverse events, concomitant medications, administering quality of life questionnaires, or other procedures required by protocol.
• 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 as necessary. Communicate with investigators and fiscal staff when financial milestones have been met.
• Record and track patient protocol visits, including procedures in the CTMS system.
• Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team.

Analysis and Reporting - 10%

• Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.
• Attend sponsor and research program meetings and report on progress of each project.
• Assist Regulatory Coordinators by preparing reports to support annual FDA submissions and IRB Continuing Review Reports.
• May perform other duties as assigned. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks.

Protocol Development - 5%

• May assist in reviewing clinical research protocols in development to ensure research objectives and procedures necessary to test the hypothesis of the research project are clearly described.
• May work with multiple UW and FHCC groups (e.g. FHCC Clinical Research Support - Clinical Readiness, IDS Pharmacy, Clinical Trials Unit) to help identify operational issues and implement a research project compliantly.

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 Life or Social Sciences or related field and 2 years clinical research project coordination experience.

Additional Qualifications

• Experience in clinical trial processes, implementation of research protocols. Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects.
• Strong computer skills and competency with Microsoft Office software. Experience using electronic data capture software.
• Strong attention to detail and ability to multi-task, organize and prioritize multiple projects simultaneously. Excellent written and verbal communication skills.
• Demonstrated ability to work independently, under supervision, and be a team player.
• Demonstrated high motivation and flexibility, with the ability to adjust to rapidly changing priorities and new projects. Maintain positive attitude and interactions and professional demeanor under potentially stressful situations.

Preferred Qualifications

• Oncology clinical trial coordination experience.
• Knowledge of University of Washington and Fred Hutch Cancer Center processes.
• Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.

Working Conditions

• This position is located in a clinical and research environment that is located on the Fred Hutch Cancer Center campus. Frequent travel/to and from office and clinic.
• Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, Teams, EMR, voicemail, fax, verbal), determining priorities.
• Work hours frequently exceed 40 hours per week and may be deadline dependent. There may be deadlines over which an individual has no control that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs. Occasional evening and weekend work (e.g. to meet deadlines; potential travel to study meetings) may be required.
• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete this training.

About the Team
The University of Washington's Division of Hematology & Oncology includes 200+ staff and 450+ 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
Pay Range Minimum:
$65,352.00 annual
Pay Range Maximum:
$85,728.00 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.