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central follow up specialist (wa)_clinical services Jobs in Seattle

clinical research associate (level ii) - fsp vaccines - west region Jobs in Seattle

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)

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

<div><p><b>Job Description
</b></p><p></p><p><b>University of Washington's Laboratory Medicine and Pathology department has outstanding opportunities for temporary MEDICAL LAB COURIERS. </b>The Medical Lab Courier is responsible for the transport of laboratory specimens, reports, supplies and other designated materials between University of Washington Medical Center and medical facilities and laboratories within Washington State.
<br>
<br>
<b>WORK SCHEDULE
</b><br>
Variable Shift
<br>
<br>
<b>PRIMARY JOB RESPONSIBILITIES
</b></p><ul><li><p>Works with bio hazardous specimens and adheres to &quot;Universal Precaution&quot; procedures.
</p></li><li><p>Prepares all lab supplies needed to be delivered to client locations.
</p></li><li><p>Drives the assigned route in appropriate amount of time.
</p></li><li><p>Maintains accurate records of route stops and specimens transported.
</p></li><li><p>Knowledgeable and adheres to UW Fleet Services rules and regulations.
</p></li><li><p>Maintains University vehicle, as per protocol.
</p></li><li><p>Utilize digital devices to manage daily pickups.
</p></li><li><p>Provides excellent customer service.
</p></li><li><p>Performs other duties as assigned.
</p></li></ul><p></p><p><b>REQUIRED POSITION QUALIFICATIONS
</b><br>
Possession of a valid Washington State vehicle operator's license.
<br>
<br>
<b>DESIRED
</b></p><ul><li><p>Safe driving record as evidenced by provision of a minimum 3-year driving abstract.
</p></li><li><p>Professional driving experience.
</p></li><li><p>Experience handling bio-hazardous laboratory specimens and familiarity with universal precautions.
</p></li><li><p>Experience with customer service relations.
</p></li><li><p>Demonstrated success working independently with minimal supervision.
</p></li></ul><p></p><p><b>ABOUT UW MEDICINE &ndash; WHERE YOUR IMPACT GOES FURTHER
</b><br>
The Department of Laboratory Medicine and Pathology serves as a regional resource for clinical laboratory services required for patient care, research and educational programs in laboratory medicine. The department now employs 1400 people who work at the award-winning University of Washington Medical Center (ranked among the top medical centers in the United States as rated by U.S. News &amp; World Report), Harborview Medical Center (the region's only Level I Trauma center, known for innovations and excellence in trauma care and its centers of emphasis: Trauma, Burn, Neurosciences, AIDS/STD CARER, and mentally- and medically- vulnerable populations.), and many other clinical and research facilities in the area. The University of Washington (UW) is proud to be one of the nation&rsquo;s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement and natural beauty.
</p><p></p><p><b>Compensation, Benefits and Position Details
</b></p><p></p><p><b>Pay Range Minimum:
</b></p>$21.77 hourly
<p><b>Pay Range Maximum:
</b></p>$22.28 hourly
<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>Alternate Work 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>0.00%
<p><b>Union/Bargaining Unit:
</b></p>SEIU Local 925 Nonsupervisory
<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>

Medical Laboratory Couriers

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><p>
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.</p><p></p><p>
Must be legally authorized to work in the United States without sponsorship.</p><p></p><p>
Must be able to pass a comprehensive background check, which includes a drug screening.</p><p></p><p>
This is a functional service provider (FSP) Clinical Research Associate (CRA) opportunity, you will be dedicated to one sponsor, monitoring seven days a month, 50% onsite and 50% remotely based on business needs. This position is targeted to travel regionally, travel can be national if needed. Ideal candidates will have one to two years of onsite pharmaceutical CRA experience.</p><p></p><p><b>
Discover Impactful Work</b></p><p>
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.</p><p></p><p><b>
A Day in the Life</b></p><ul><li><p>
Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</p></li><li><p>
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</p></li><li><p>
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</p></li><li><p>
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</p></li><li><p>
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</p></li><li><p>
Responds to company, client and applicable regulatory requirements/audits/inspections.</p></li><li><p>
Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</p></li><li><p>
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</p></li><li><p>
Contributes to other project work and initiatives for process improvement, as required.</p></li></ul><p></p><p><b>
Keys to Success</b></p><p><b>
Education and Experience</b></p><p>
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</p><p>
Valid driver's license where applicable.</p><p></p><p><b>
CRA Level II
</b></p><p>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years as a clinical research monitor).</p><p></p><p>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role</p><p></p><p><b>
Knowledge, Skills, Abilities</b></p><ul><li><p>
Proven clinical monitoring skills, ideal candidates will have monitoring experience with oncology, HIV, respiratory and or vaccine/flu</p></li><li><p>
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</p></li><li><p>
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</p></li><li><p>
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving</p></li><li><p>
Ability to manage Risk Based Monitoring concepts and processes</p></li><li><p>
Good oral and written communication skills, with the ability to communicate effectively with medical personnel</p></li><li><p>
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</p></li><li><p>
Good organizational and time management skills</p></li><li><p>
Effective interpersonal skills</p></li><li><p>
Attention to detail</p></li><li><p>
Ability to remain flexible and adaptable in a wide range of scenarios</p></li><li><p>
Ability to work in a team or independently as required</p></li><li><p>
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</p></li><li><p>
Good English language and grammar skills</p></li><li><p>
Good presentation skills</p></li></ul><p></p><p><b><i>
Work Environment:</i></b></p><p><i>
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:</i></p><ul><li><p>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</p></li><li><p>
Able to work upright and stationary for typical working hours.</p></li><li><p>
Ability to use and learn standard office equipment and technology with proficiency.</p></li><li><p>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</p></li></ul><p></p><p><b>
Compensation and Benefits</b></p>
The salary range estimated for this position based in Washington is $66,800.00&ndash;$112,938.00.<p></p><p>
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:</p><ul><li><p>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</p></li><li><p>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</p></li><li><p>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</p></li><li><p>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</p></li><li><p>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</p></li></ul><p></p><p>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</p></div><p></p>

Clinical Research Associate (Level II) - FSP Vaccines - West Region

Explore 95+ Clinical trials budget specialist temporary in Seattle this May. Find roles across top companies and apply now to boost your career.