accounts payable specialist i

clinical research coordinator i Jobs in Seattle

clinical research coordinator i

clinical research coordinator ii Jobs in Seattle

clinical research coordinator ii

clinical research coordinator ii - intake Jobs in Seattle

clinical research coordinator iii Jobs in Seattle

clinical research coordinator iii

clinical trials budget specialist temporary

University Of Washington

<div><p><b>Job Description
</b></p><p></p><p><b>The Division of Hematology and Oncology has an outstanding opportunity for a Clinical Trials Budget Specialist to join their team in a limited-term appointment.
</b></p><p></p><p><b>About this Opportunity:
</b></p><p>Reporting to the Clinical Research Budget Manager, this position works closely with research faculty and staff and is responsible for clinical research budgeting and revenue cycle strategy, development and oversight. Specifically, this position oversees and negotiates optimal pricing and payment terms for investigator initiated and industry sponsored clinical trials, ensuring regulatory compliance and fiscal accountability.
</p><p></p><p><b>KEY RESPONSIBILITIES
</b></p><p></p><p>Clinical Trial Budget Development, Revenue Cycle, and Financial Risk Management :
</p><ul><li>Perform comprehensive and independent review of all documents related to the research study funding, including study budget, protocol, consent form, contract, and other supporting documentation.
</li><li>In collaboration with Principal Investigators, identify and differentiate between research-specific procedures and standard of care.
</li><li>Using established systems and committees, seek appropriate prices quotes from University of Washington, Fred Hutch Cancer Center, and other partner institution service departments. Independently negotiate successful clinical trial budgets and payment terms with study sponsors.
</li><li>Coordinate with disease program research staff to ensure each study&rsquo;s consent form delineates research care and standard of care.
</li><li>Coordinate with UW and FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, and the FHCC Research Implementation Office.
</li></ul><p></p><p>Post Award Revenue Recovery :
</p><ul><li>Perform comprehensive and independent review of patient activity, and in comparison to the Clinical Trial Agreement, perform complex financial reconciliations to ensure full revenue recovery.
</li><li>Identify invoiceable items in contracts and ensure regular invoicing and accounts receivable aging follow up.
</li><li>Use CTMS system, ONCORE, for financial reconciliation of studies that are operational in that system. Independently troubleshoot payment issues with sponsors in a timely manner.
</li><li>Identify and assist faculty to mitigate budget deficits, including communication with sponsor for amendments.
</li></ul><p></p><p><b>Required Qualifications:
</b></p><p>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.
</p><p></p><p><b>MINIMUM REQUIREMENTS
</b></p><p>Bachelor's Degree in Business, Science, or Health-related field and a minimum of three years&rsquo; experience with clinical research budget development, clinical research coordination, or related research or healthcare experience.
</p><p></p><p>Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
</p><p></p><p><b>DESIRED REQUIREMENTS
</b></p><ul><li>Ability to work effectively and efficiently in a group environment
</li><li>Exceptional organizational and customer service skills
</li><li>Strong written and oral presentation skills
</li><li>Ability to communicate effectively with all levels of faculty, management and clinical research staff
</li><li>Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
</li><li>Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely
</li><li>Ability to prioritize and organize work independently
</li><li>Demonstrated skill in using Microsoft Excel
</li><li>Experience in an academic medical center
</li><li>Experience negotiating clinical trial budget and payment terms
</li><li>Experience as a research study coordinator
</li><li>Experience in oncology clinical research
</li><li>Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols.
</li><li>Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations
</li><li>Experience with using International Classification of Diseases, 9th Revision (ICD-9), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment
</li><li>Strong working knowledge Microsoft Office Suite
</li><li>Experience using Epic for Research charge routing is highly desirable
</li><li>Experience using OnCore is highly desirable
</li></ul><p></p><p><b>WORKING CONDITIONS
</b></p><ul><li>Fast-paced office environment, with a high volume of often-complex projects.
</li><li>The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day.
</li><li>Work week regularly exceeds 40 hours per week.
</li><li>The position is a 100% remote position and requires working during the regular business hours of the institution.
</li><li>This position requires a flexible work schedule. Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.
</li></ul><p></p><p><b>Compensation, Benefits and Position Details
</b></p><p></p><p><b>Pay Range Minimum:
</b></p>$80,004.00 annual
<p><b>Pay Range Maximum:
</b></p>$104,568.00 annual
<p><b>Other Compensation:
</b></p><ul><li></li></ul><p><b>Benefits:
</b></p>For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-temporary-per-diem-and-less-than-half-time/
<p><b>Shift:
</b></p>First Shift (United States of America)
<p><b>Temporary or Regular?
</b></p>This is a temporary position
<p><b>FTE (Full-Time Equivalent):
</b></p>100.00%
<p><b>Union/Bargaining Unit:
</b></p>Not Applicable
<p></p><p><b>About the UW
</b></p><p></p><p>Working at the University of Washington provides a unique opportunity to change lives &ndash; on our campuses, in our state and around the world.
</p><p></p><p>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.
</p><p></p><p><b>Our Commitment
</b></p><p></p><p>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 .
</p><p></p><p>To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .
</p><p></p><p>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 .</p></div>

Clinical Trials Budget Specialist (Temporary)

<div><p><b>Job Description
</b></p><p></p><p><b>The Department of Neurology </b><b>has an outstanding opportunity for </b><b>100% FTE Research Coordinator 1.
</b></p><p></p><p><b>About This Opportunity
</b></p><p>Reporting to the Principal Investigator the Research Coordinator will be responsible for the coordination and implementation of research projects that focus on the understanding, treatment, and outcomes of stroke. This individual will develop and review research tools and protocols, maintain IRB approvals and consent forms, and participate in data collection and data management for NIH and industry sponsored projects. Additional duties may include, but are not limited to, coordinating multiple data collection efforts with other institutions, designing the phases of the research projects, recruiting and overseeing recruitment of human subjects, writing and editing reports, data management, and preparing conference presentations and manuscripts for publication.
</p><p></p><p>This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This individual will develop procedures that ensure that all research meets or exceeds these requirements. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the research objectives. This individual is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. They will also be responsible for maintaining communication with researchers at other universities.
</p><p></p><p>The individual in this position will aid in furthering the academic pursuit of the UW by contributing their time and knowledge base to our research studies.
</p><p></p><p><b>Key Responsibilities
</b></p><p></p><p><b><i>Patient Management - 50%
</i></b></p><ul><li><p>Identify, consent, enroll and follow up patients in clinical trials. Assist in scheduling appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Assist in monitoring and administering patient protocol, interacting closely with clinical providers to ensure patient safety and protocol adherence.
</p></li><li><p>Communicate with outside physicians who are interested in referring patients to UWMC/HMC for clinical trials in stroke.
</p></li><li><p>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 research staff when financial milestones have been met.
</p></li></ul><p></p><p><b><i>Protocol Management - 40%
</i></b></p><ul><li><p>Develop and implement research project procedures that 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).
</p></li><li><p>Design, create, revise, and complete research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.
</p></li><li><p>Design, develop, document and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
</p></li><li><p>Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
</p></li></ul><p></p><p><b><i>Analysis and Reporting - 10%
</i></b></p><ul><li><p>Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion. Assist in analyzing data to be presented at conferences or published in scientific journals.
</p></li><li><p>Assist in financial audits and communicate with research investigators when financial milestones have been met.
</p></li><li><p>Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.
</p></li></ul><p></p><p>Other duties as assigned.
</p><p></p><p><b>Required Qualifications
</b></p><p>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.
</p><p></p><p><b>Minimum Qualifications
</b></p><ul><li><p>Bachelor&rsquo;s degree in a related field and one year of relevant experience.
</p></li><li><p>Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
</p></li><li><b>Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.
</b></li></ul><p></p><p><b>Additional Qualifications
</b></p><ul><li><p>Knowledge and prior experience with human subject&rsquo;s institutional review process including developing protocols and working with the IRB for approvals.
</p></li><li><p>Strong writing skills including a demonstrated ability to write for publication in peer-reviewed scientific journals.
</p></li><li><p>Strong project management skills.
</p></li><li><p>Background and experience conducting research projects that met programmatic and regulatory requirements.
</p></li><li><p>Training and/or knowledge in ethical conduct of research with human subjects.
</p></li><li><p>Ability to work as a collaborative, cooperative, and congenial member of a close knit scholarly and administrative team, as well as work independently.
</p></li></ul><p></p><p><b>Preferred Qualifications
</b></p><ul><li><p>Certifications in Health Information Portability and Accountability Act and Human Subject Research.
</p></li></ul><p></p><p><b>Compensation, Benefits and Position Details
</b></p><p></p><p><b>Pay Range Minimum:
</b></p>$55,944.00 annual
<p><b>Pay Range Maximum:
</b></p>$64,992.00 annual
<p><b>Other Compensation:
</b></p><ul><li></li></ul><p><b>Benefits:
</b></p>For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
<p><b>Shift:
</b></p>First Shift (United States of America)
<p><b>Temporary or Regular?
</b></p>This is a regular position
<p><b>FTE (Full-Time Equivalent):
</b></p>100.00%
<p><b>Union/Bargaining Unit:
</b></p>UAW Research
<p></p><p><b>About the UW
</b></p><p></p><p>Working at the University of Washington provides a unique opportunity to change lives &ndash; on our campuses, in our state and around the world.
</p><p></p><p>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.
</p><p></p><p><b>Our Commitment
</b></p><p></p><p>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 .
</p><p></p><p>To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .
</p><p></p><p>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 .</p></div>

Research Coordinator 1

Fred Hutchinson Cancer Center

<div>Overview:
<div>
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.</div><div></div><div><br>
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world&rsquo;s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world&rsquo;s deadliest diseases and make life beyond cancer a reality.</div><div></div><div><br>
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.</div><div></div><div><br>
The Clinical Research Coordinator III coordinates all aspects of clinical research trials except those that require medical expertise or licensure.</div><div></div><div><br>
The Clinical Research Coordinator III is a senior coordinator role on the UW Phase 1 Clinical Trial Program that supports oncology clinical trials conducted at the Fred Hutch/University of Washington Cancer Consortium. The position will work directly with hospital, clinic and research staff in the development, implementation and management of clinical trials. The position is responsible for the collection, coordination, processing, and quality control of clinical trial data in accordance with protocols subject to FDA oversight. Responsible for coordination of long-term follow-up activities associated with these protocols. Uses judgment in data collection, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch/Seattle Children&rsquo;s UW system including the Fred Hutch Transplant Service. This individual will work under limited supervision of the Associate Director of Clinical Trial Coordination and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines.</div><div></div><div><br>
At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.</div><br>
<div></div>
Responsibilities:
<ul><li>Review and maintain familiarity with research protocols with regard to data collection.</li><li>
Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up.</li><li>
Evaluate patient eligibility for clinical trials and assist in screening and patient enrollment.</li><li>
Understand and interact with departments and automated systems throughout Fred Hutch/Seattle children&rsquo;s/UW system to ensure timely and complete delivery of data.</li><li>
Track status of potential and active clinical trial participants.</li><li>
Manage long-term follow-up evaluations and data collection with clinical trial participants, Fred Hutch/Seattle children&rsquo;s, and participants&rsquo; local physicians.</li><li>
Develop data acquisition forms and instructions for completion.</li><li>
Manage and work with computer application specialists to ensure consistency between paper and electronic data systems.</li><li>
Manage monitoring visits and quality control reviews by Sponsors or Investigators.</li><li>
Support regularly scheduled institutional monitoring visits by Sponsors or Investigators to ensure quality and completeness of data.</li><li>
Serve as a liaison and reference resource to Physicians, Investigators, other staff members, and other organizations with questions about data collection or protocol procedures and requirements.</li><li>
Manage special projects regarding data collection, analysis, output, and presentation.</li><li>
Provide input to support policies and goals of the program. Manage submission of reports in conjunction with the PI and Associate Director to the Human Subjects Committee, Institutional Review Board, Radiation Safety</li><li>
Committee, Federal Drug Administration, Pharmaceutical Companies, and other agencies.</li><li>
Liaise with Institutional Review Boards (IRB&rsquo;s) in submission of protocol, study amendments, annual reporting and adverse event reporting.</li><li>
Perform other responsibilities as required.</li></ul>
Qualifications:
<div><b>
MINIMUM QUALIFICATIONS:</b></div><ul><li>
Bachelor&rsquo;s Degree in scientific/medical field or equivalent combination of education and experience.</li><li>
Six or more years of experience in medical records, cancer registry, clinical study coordination or related field.</li></ul><div><b>
PREFERRED QUALIFICATIONS:</b></div><ul><li>
Preferred Advanced Degree (Master&rsquo;s level or higher) in the scientific/medical field.
</li><li>Clinical Research Associate (CRA) certification is highly desirable.</li><li>
Strong computer skills, including proficiency in Excel and Word, and experience working with databases.</li><li>
Strong verbal and written communication skills.</li><li>
Knowledge of medical terminology.</li></ul><p></p><div>
The annual base salary range for this position is from $80,172 to $114,941, and pay offered will be based on experience and qualifications.<br>
<br>
Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.<br>
<br>
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).</div>
Additional Information: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.</div>

Clinical Research Coordinator III

<div>Overview:
<div>
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.</div><div></div><div><br>
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world&rsquo;s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world&rsquo;s deadliest diseases and make life beyond cancer a reality.</div><div></div><div><br>
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.</div><div></div><div><br>
The <b>Clinical Research Intake Coordinator</b> is responsible for supporting the intake, prescreening, and initial coordination activities for patients being considered for Phase I&ndash;III interventional trials and observational research studies. This position oversees subject level intake workflows, including reviewing medical histories, assessing preliminary eligibility based on protocol criteria, coordinating prescreening activities, and serving as an early patient point-of-contact. The Intake Coordinator engages directly with patients and families to provide education about research participation, address questions, and guide them through the initial steps of the clinical trial process. The role ensures timely collection and organization of eligibility documentation, maintains prescreening and enrollment trackers, and collaborates closely with research and clinical teams to support efficient and compliant trial enrollment.</div><div></div><div><br>
Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the Intake Coordinator is an integral member of specialized Oncology research teams and contributes to the smooth operation of clinical trials and the advancement of research efforts at Fred Hutch.</div><div></div><div><br>
At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.</div>
Responsibilities:
<ul><li>Conduct clinical prescreening by reviewing medical histories, current medications, and protocol inclusion/exclusion criteria to assess preliminary eligibility.
</li><li>Serve as the primary point of contact for referred patients, providing clear communication, guidance, and education on clinical trial processes and timelines.
</li><li>Coordinate scheduling of prescreening appointments, provider consults, and required diagnostic or laboratory evaluations.
</li><li>Collaborate with referring providers, treating physicians, and research teams to validate eligibility and ensure continuity of clinical and research care.
</li><li>Facilitate patient navigation through the enrollment pathway, addressing barriers, answering questions, and supporting informed decision-making.
</li><li>Manage intake workflows for early phase studies, including real-time monitoring of slot availability and patient queue management aligned with sponsor timelines.
</li><li>Obtain necessary medical records, prior therapy documentation, and required authorizations in accordance with institutional and sponsor requirements.
</li><li>Accurately abstract, document, and track prescreening and enrollment data in CRFs, EMR, and research databases; maintain compliant research files and logs.
</li><li>Coordinate with multidisciplinary teams (lab, radiology, pathology, pharmacy, and clinical operations) to ensure protocol-required procedures are completed.
</li><li>Participate in team meetings, study start-up activities, and provide research coordination support during staffing gaps.</li><li>
Support process improvement initiatives by identifying workflow gaps, proposing solutions, and contributing to the development of standardized intake and prescreening procedures.
</li><li>Ensure compliance with institutional policies, GCP/ICH guidelines, and regulatory requirements throughout all intake, prescreening, and enrollment activities.</li></ul>
Qualifications:
<div>
<b>MINIMUM QUALIFICATIONS:</b></div><ul><li>
High school diploma or equivalent.
<br>
</li><li>Minimum two to three years&rsquo; experience in a clinical research or cancer registry environment with regulatory or human research protections.
<br>
</li><li>Knowledge of clinical trials records, procedures, and computerized data processing systems.
<br>
</li><li>Demonstrated knowledge of how to synthesize study conduct.
</li></ul><div><b>PREFERRED QUALIFICATIONS:</b></div><ul><li>
Associate or bachelor&rsquo;s degree preferred.</li><li>
Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
</li><li>Working knowledge with NIH, FDA, and OHRP regulations, as well as medical terminology relevant to clinical research and patient communication.</li><li>
Prior experience in oncology environments, including clinical, research, or patient navigation settings.</li><li>
Excellent organizational skills, attention to detail, ability to solve problems and to prioritize multiple competing tasks in a dynamic environment.
</li><li>Strong written and verbal communication skills, including computer skills.
</li><li>Ability to work with multiple data management systems including generating reports and sourcing data from systems.
</li><li>Ability to extract data from medical records and apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.</li></ul><p></p><div>
The hourly pay range for this position is from $31.83 to $47.73 and pay offered will be based on experience and qualifications.<br>
<br>
Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.<br>
<br>
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).</div>
Additional Information: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.</div>

Clinical Research Coordinator II - Intake

<div>Overview:
<div>
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.</div><div></div><div><br>
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world&rsquo;s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world&rsquo;s deadliest diseases and make life beyond cancer a reality.</div><div></div><div><br>
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.</div><div></div><div><br>
The<b> Clinical Research Coordinator II</b> (CRC II) is responsible for day-to-day management of oncology clinical trials. The position will oversee all subject-level study workflows including screening patients for eligibility, coordinating and tracking patient visits and procedures, and creating and maintaining research documentation. The position interfaces with the clinic, providers, investigators, and teams across the clinical research enterprise.</div>
Responsibilities:
<ul><li>Conduct daily clinical operations of assigned research studies in accordance with study protocols, GCP guidelines, applicable regulatory requirements and institutional policies.</li><li>
Coordinate patient enrollment and participation by reviewing study candidates&rsquo; medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
</li><li>Schedule patient clinic visits and on-going study visits; ensure compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires and ensure drug self-administration accountability with patients.</li><li>
Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.</li><li>
Identify, track and confirm billable activities for patients; work with internal finance team to assist in reviewing clinic charges to ensure billing compliance.</li><li>
Act as protocol liaison with clinical teams, patients, and providers on study related topics.</li><li>
Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up with and resolving any issues that may arise.</li><li>
Assist with maintaining appropriate source documentation and/or performing case report form (CRF) data entry.</li><li>
May travel from South Lake Union campus on shuttle to UW Medical Center (UWMC) Montlake to coordinate patient visits.</li><li>
Other duties as assigned</li></ul>
Qualifications:
<div><b>
MINIMUM QUALIFICATIONS:</b></div><br>
<ul><li>
High school diploma or equivalent.</li><li>
Minimum two to three years&rsquo; experience in a clinical research or cancer registry environment with regulatory or human research protections.</li><li>
Knowledge of clinical trials records, procedures, and computerized data processing systems.</li><li>
Demonstrated knowledge of how to synthesize study conduct.</li></ul><div><b>
PREFERRED QUALIFICATIONS:</b></div><ul><li>
Associate or bachelor&rsquo;s degree preferred.</li><li>
Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).</li><li>
Five years of experience working in clinical research, preferably oncology interventional trials.</li><li>
Working understanding of applicable regulations and guidelines including FDA, ICH GCP, and HHS</li><li>
Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.Strong written and verbal communication skills, including computer skills.</li><li>
Ability to work with multiple data management systems including generating reports and sourcing data from systems.</li><li>
Ability to extract data from medical records and apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.</li></ul><p></p><div>
The hourly pay range for this position is from $31.83 to $47.73 and pay offered will be based on experience and qualifications.<br>
<br>
Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.<br>
<br>
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).</div>
Additional Information: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.</div>

Clinical Research Coordinator II

<div>Overview:
<div>
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.</div><div></div><div><br>
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world&rsquo;s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world&rsquo;s deadliest diseases and make life beyond cancer a reality.</div><div></div><div><br>
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.</div><div></div><div><br>
The <b>Clinical Research Coordinator I (CRC I) </b>assists with the day-to-day coordination of interventional, oncology clinical trials. Coordination activities include participant/patient eligibility review, coordinating and tracking patient visits and procedures, managing patient lab kits, and creating and maintaining research documentation. The position interfaces with the clinic, providers, investigators, and teams across the clinical research enterprise.</div><div></div><div><br>
Reporting to the Program Manager, this position is key to the smooth operation of clinical trials and advancing research efforts at Fred Hutch.</div>
Responsibilities:
<ul><li>Coordinate and assist in carrying out daily clinical operations of assigned research studies in accordance with study protocols, institutional policies and Standard Operating Procedures (SOPs), and applicable regulations and guidance.</li><li>
Assist with patient enrollment and participation by reviewing study candidates&rsquo; medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.</li><li>
Schedule patient clinic visits and on-going study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires and ensure drug self-administration accountability with patients.</li><li>
Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples and ensure samples are processed and shipped according to protocol requirements; track and maintain research supplies.</li><li>
Act as protocol liaison with clinical teams, patients, and providers on study related topics.</li><li>
Assist in preparing for and coordinating monitoring visits and assist in responding to queries and other requests from study monitors.</li><li>
May assist with maintaining appropriate source documentation and/or performing case report form data entry.</li><li>
Other duties as assigned.</li></ul>
Qualifications:
<div><b>
MINIMUM QUALIFICATIONS:</b></div><ul><li>
High school diploma or equivalent.
<br>
</li><li>Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
<br>
</li><li>Demonstrated knowledge of how to synthesis study conduct.
<br>
</li><li>Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.</li></ul><p><b>
PREFERRED QUALIFICATIONS:
</b></p><ul><li>Associate or bachelor&rsquo;s degree preferred.</li><li>
Knowledge of clinical trials, procedures, and applicable systems, preferably in an oncology setting.</li><li>
Ability to extract data from medical records.</li><li>
Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.</li><li>
Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.</li></ul><p></p><div>
The hourly pay range for this position is from $27.01 to $38.45 and pay offered will be based on experience and qualifications.<br>
<br>
Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.<br>
<br>
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).</div>
Additional Information: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.</div>

Clinical Research Coordinator I

Umoja Biopharma

<div><div><p>Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.</p>
<p>
Umoja Biopharma &ndash; Your Body. Your Hope. Your Cure.</p></div><p><b>
POSITION SUMMARY</b><b>
</b></p><p>The Senior Director, Clinical Data Management will provide strategic and operational leadership for all clinical data management activities across Umoja's clinical development programs. This role sits within the Clinical organization and is accountable for ensuring the integrity, quality, and regulatory compliance of clinical trial data from protocol development through database lock and regulatory submission.</p>
<p>
This individual will lead the planning, execution, and oversight of data management activities, clinical systems, and external vendors, while building scalable processes and capabilities to support a growing clinical pipeline. The role partners closely with Clinical Development, Clinical Operations, Biostatistics, Translational Medicine, Regulatory Affairs, and external partners like CROs to ensure timely delivery of high quality, decision-read‑y‑ clinical data.</p>
<p>
This role will be an Individual Contributor and will lead a matrixed team of vendors (CROs) and contractors to start. This person will be responsible for building out a future team.</p>
<p>
This role will ideally be based in Seattle, WA or Louisville, CO but can be remote within the US. If remote, travel to Umoja Headquarters will be required at least once per quarter.</p>
<p><b>
CORE ACCOUNTABILITIES</b></p>
<p><b>
Specific Responsibilities include:</b><br>
<b>Hands‑On Clinical Data Management Execution (as needed while building CDM team)</b></p>
<ul>
<li>Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.</li>
<li>Perform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirements.</li>
<li>Lead hands-on CRF design and review, ensuring alignment with protocol objectives‑, statistical analysis plans, and regulatory expectations.</li>
<li>Develop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plans.</li>
<li>Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.</li>
<li>Perform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready‑ datasets.</li>
</ul>
<p><b>Technical Oversight &amp; Data Quality</b></p>
<ul>
<li>Partner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk based‑monitoring approaches for clinical data.</li>
<li>Lead hands-on‑oversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation management.</li>
<li>Directly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical Programming.</li>
<li>Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.</li>
<li>Support inspection readiness activities by authoring, reviewing, and maintaining data management documentation and responding directly to audit and inspection findings.</li>
</ul>
<p><b>Cross Functional Collaboration</b></p>
<ul>
<li>Partner closely with Clinical Operations to align data management activities with study execution, site operations, monitoring strategies, and operational reporting needs.</li>
<li>Collaborate with Biostatistics and Statistical Programming to ensure smooth handoff of clean, well documented- datasets for analysis and reporting.</li>
<li>Provide technical data management expertise to Regulatory Affairs in support of clinical study reports, INDs, BLAs, and other regulatory submissions.</li>
<li>Serve as the clinical data management subject matter‑ expert on study teams, governance forums, and internal reviews.</li>
</ul>
<p><b>Process &amp; Systems Ownership</b></p>
<ul>
<li>Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization.</li>
<li>Evaluate, implement, and optimize clinical data systems and technologies (e.g., EDC, IRT, eCOA) to enhance data quality, traceability, and scalability.</li>
<li>Contribute hands‑on to vendor selection, scope definition, and budgeting for data management services and systems.</li>
</ul>
<p><b>The successful candidate will have:</b></p>
<ul>
<li>Bachelor's degree or higher in life sciences, health informatics, computer science, or a related discipline with a minimum of 15 years of experience. Equivalent combinations of education and experience will be considered.</li>
<li>Significant experience in clinical data management within the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trials.</li>
<li>Demonstrated experience overseeing CROs and external vendors delivering clinical data management services.</li>
<li>Strong working knowledge of clinical trial processes, EDC systems, data standards, and regulatory expectations for clinical data.</li>
<li>Proven ability to lead teams, manage complex programs, and collaborate effectively in a fast‑paced, matrixed environment.</li>
<li>Excellent written and verbal communication skills.</li>
</ul>
<p><b>Preferred Qualifications</b>:</p>
<ul>
<li>Experience supporting oncology and/or cell or gene therapy clinical development programs.</li>
<li>Experience building or scaling clinical data management capabilities in a growing biotech organization.</li>
<li>Prior involvement in regulatory submissions and inspection readiness activities.</li>
</ul>
<p><b>Physical Requirements</b></p>
<ul>
<li>Preference to work onsite at least 2 days/week in our Seattle, WA or Louisville, CO location. If remote, the ability to travel to Seattle, WA at least once per quarter.</li>
<li>Ability to sit for prolonged periods of time.</li>
</ul>
<p><b>Salary Range: $247,400 - $305,600</b></p><div><h4 class="jobSectionHeader"><b>
Benefits Offerings</b></h4>
<p><i>
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the </i><b><i>Benefits</i></b><i> section of our website.</i></p></div></div>

Senior Director, Clinical Data Management

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