clinical research associate level ii fsp vaccines west region

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

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<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 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

Fred Hutch

<div>
 <strong>
  Overview
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <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.
 <br/>
 <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.
 <br/>
 <br/>
 The Clinical Research Specimen Processing Laboratory (CRSP) Quality Assurance Coordinator ensures feasibility and compliance with relevant clinical research requirements and conducts quality control and assurance activities. This role will interact with the various departments and staff engaged in clinical research, such as investigators, study teams, and laboratory and clinic staff. Additionally, this position will ensure continuity of accurate service through quality control documentation. Role will oversee the data input into the CRSP Laboratory Information Management System (LIMS) and generate metrics upon request.
 <br/>
 <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.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Study Compliance: Use high level organizational skills and clinical research experience to review clinical protocol and study manuals for accuracy and feasibility. Extract pertinent details for entry into Fred Hutch CRSP LIMS system. Maintain up to date database information to ensure accurate processing of study samples.
  </li>
  <li>
   Quality Control: Maintain relevant study documents on behalf of CRSP including but not limited to protocols, study/laboratory manuals, amendments, etc. Update internal study documents as changes occur. Perform periodic verification of data entry into LIMS system. Works with Core Director and Clinical Research Team to investigate any study compliance concerns pertaining to CRSP.
  </li>
  <li>
   Collaboration: Advise PIs/Study teams on protocol development to ensure correct specimen workflows and processing procedures. Prepare for and attend all relevant Site Initiation Visits to allow information exchange in optimizing CRSP-relevant portions of clinical protocols/study manuals. Establish and maintain positive working relationships with investigators and study managers, soliciting feedback to establish present and future needs and helping as requested.
  </li>
  <li>
   Operations Oversight: Work with LIMS development team to continue to refine and improve study onboarding and management of specimen submission. Train CRSP and/or study staff on appropriate standard operating procedures related to CRSP.
  </li>
  <li>
   Teamwork: Evaluate data and use direct observations to identify and recommend ways to improve CRSP Team efficiency and clinical research compliance. Provide support for specimen processing and other laboratory activities. Other duties as assigned by the CRSP Director.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <strong>
  MINIMUM QUALIFICATIONS:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   High school diploma or equivalent.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree (preferably in Biology or health sciences) and 1-2 years clinical research experience, OR
  </li>
  <li>
   Associate degree and 3+ years of experience
  </li>
  <li>
   Clinical trial knowledge/experience and demonstrated understanding of required materials such as clinical protocols and laboratory manuals provided by pharmaceutical companies for clinical investigations.
  </li>
  <li>
   Ability to critically review clinical protocols and complex laboratory manuals.
  </li>
  <li>
   Demonstrated performance to provide leadership, training, and problem-solving.
  </li>
  <li>
   Represent CRSP during meetings or other communications with investigators, study team members, and sponsors.
  </li>
  <li>
   Understanding of quality assurance and feasibility as applied to clinical research studies.
  </li>
  <li>
   Familiarity with basic laboratory information management system concepts.
  </li>
  <li>
   Knowledge of basic clinical protocol design and terminology.
  </li>
  <li>
   Knowledge of basic specimen acquisition processing and terminology.
  </li>
  <li>
   Ability to work on multiple tasks and establish priorities.
   <br/>
   <br/>
  </li>
 </ul>
 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).
 <br/>
 <br/>
 <strong>
  Additional Information
  <br/>
  <br/>
 </strong>
 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>


Quality Assurance Coordinator

<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 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

Seattle Children's

<div><p>As a Clinical Research Coordinator II you will support two research program, the Community Engagement Core and the Pediatric Pain and Sleep Innovations (PPSI) lab. The Community Engagement Core provides multilingual, community-oriented research services to research teams throughout Seattle Children&rsquo;s Research Institute with a focus on reducing barriers to community engaged research. The Pediatric Pain and Sleep Innovations (PPSI) lab conducts clinical and community research around pediatric pain and sleep health, along with how the two intersect.</p><p></p><p>
These studies include English and Spanish-speaking participants and selected applicants will be required to pass a Spanish fluency test.
</p><p></p><p>The ideal candidate for this role would be bilingual in English and Spanish with research coordination experience in the domains of:</p><ul><li><p>
Participant engagement (e.g., recruitment, consent)</p></li><li><p>
Administering assessments, follow-ups, and incentives</p></li><li><p>
Data collection, tracking, and cleaning</p></li><li><p>
Must have strong communication skills and attention to detail</p></li><li><p>
Must be available to travel to facilitate study activities at clinics and community-based settings.</p></li></ul><p><br>
</p><b>Required Education and Experience</b><br>
Bachelor&rsquo;s Degree in related discipline, or equivalent combination of education and experience. Minimum of two (2) years of research-related experience OR Master&rsquo;s Degree in related discipline and one (1) year of research-related experience. Confirmed proficiency in a second language via successful completion of a language assessment may be required for certain departments.<br>
<br>
<b>Required Credentials</b>
<br>
Current Driver's license from the state of residence may be required for certain departments.<br>
<br>
<b>Preferred</b><br>
Master&rsquo;s Degree in a scientific discipline or related field. CCRA certification. Database management skills. Pediatric research experience.<p></p><p><b>
Compensation Range</b></p>
$35.28 - $52.92 per hour<p></p><p><b>
Salary Information</b></p><p>
This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided.</p><p></p><div><p><b>
Disclaimer for Out of State Applicants</b></p><p>
This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors<b>.</b></p><p></p><div><p><b>
Benefits Information</b></p><p>
Seattle Children&rsquo;s offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. Additional details on our benefits can be found on our website www.seattlechildrens.org/careers/benefits.</p><p></p><div><p><b>
About Us</b></p><p><b>
Hope. Care. Cure. These three simple words capture what we do at Seattle Children&rsquo;s &ndash; to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE</b></p><p></p><p>
Our founding promise to the community is as valid today as it was over a century ago: we will care for all children in our region, regardless of the families&rsquo; ability to pay. Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana and Idaho &ndash; the largest region of any children&rsquo;s hospital in the country.<br>
<br>
U.S. News &amp; World Report consistently ranks Seattle Children&rsquo;s among the nation&rsquo;s best children&rsquo;s hospitals. For more than a decade, Seattle Children&rsquo;s has been nationally recognized in key specialty areas. We are honored to be one of the nation&rsquo;s very best places to care for children and the top-ranked pediatric hospital in Washington and the Pacific Northwest.</p><p></p><p>
As a Magnet designated institution, we recognize the importance of hiring and developing great talent to provide best-in-class care to the patients and families we serve. Our organizational DNA takes form in our core values: Compassion, Excellence, Integrity, Collaboration, Equity and Innovation. Whether it&rsquo;s delivering frontline care to our patients in a kind and caring manner, practicing the highest standards of quality and safety, or being relentlessly curious as we work towards eradicating childhood diseases, these values are the fabric of our culture and community. The future starts here.</p><p></p><p><b>
Our Commitment
</b></p><p>Seattle Children&rsquo;s welcomes people of all experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our patients and families. Our organization recruits, employs, trains, compensates, and promotes based on merit without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.</p><p></p><p>
The people who work at Seattle Children&rsquo;s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves.</p><p></p><p>
Seattle Children&rsquo;s is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.</p></div></div></div></div>

Clinical Research Coordinator II - Bilingual (Spanish)

Explore 266+ Clinical research associate level ii fsp vaccines west region in Seattle this April. Find roles across top companies and apply now to boost your career.