clinical data associate

Cleveland Clinic Abu Dhabi

<div>
 <p>
  <strong>
   About the Role
  </strong>
 </p>
 <p>
  This position is responsible for providing analytic support (data abstraction, analysis, investigation, reporting and follow-up) for clinical, administrative, and quality indicators from internal and external initiatives to improve patient care and clinical outcomes. Additionally, this position provides data and reports to support quality management, patient safety, performance improvement, and clinical documentation processes.
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 </p>
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  <strong>
   Responsibilities
  </strong>
 </p>
 <ul>
  <li>
   Gathers data via medical record chart review, database queries and reporting workbench reports.
  </li>
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   Integrates clinical background with registry specific abstraction principles to accurately determine inclusion and exclusion criteria for both diagnosis and procedural related codes for the process and outcomes measure databases which CCAD actively participates.
  </li>
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   Analyzes data against quality indicators using complex standards and protocols according to National and International clinical guidelines.
  </li>
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   Abstracts and validates metrics related to hospital accreditation, specialty certification and Department of Health regulatory requirements.
  </li>
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   Uses clinical knowledge to identify trends related to clinical outcomes.
  </li>
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   Uses clinical knowledge to determine appropriateness of results and ensures accuracy of clinical and administrative data queries.
  </li>
  <li>
   Develops reports in graphical format, using reporting systems, for review and distribution to various hospital or medical staff committees.
  </li>
  <li>
   Works closely with Clinical Registry Reporting Manager in validating abstraction of outcomes registry data.
  </li>
  <li>
   Provides data analysis for decision support in the Performance Improvement Process; clearly and succinctly communicates to PI Team and clinical stakeholders the rationale and analysis of abstracted data for the purposes of a Performance Improvement Project.
  </li>
  <li>
   Maintains content expert understanding of the definitions and algorithms for clinical registry, outcomes and quality and patient safety measures as changes are announced; ability to clearly communicate same to IT Team to facilitate in the development, testing and validation of electronic tools intended to electronically capture discrete data for data registry reporting and validation.
  </li>
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   Ability to clearly communicate with and educate staff in registry reporting changes and resultant impact on documentation practices.
  </li>
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   Assists with special projects as needed.
  </li>
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   Performs other duties as assigned.
  </li>
 </ul>
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 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <ul>
  <li>
   Nursing degree is required.
  </li>
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   Bachelor&rsquo;s degree is required.
  </li>
  <li>
   Minimum of Associate degree is required.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Required Skills
  </strong>
 </p>
 <ul>
  <li>
   Minimum of two (2) years of clinical experience and working knowledge of general hospital operations, workflows and clinical documentation requirements.
  </li>
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   Minimum of one (1) year experience in a role requiring chart review, analysis of data from a medical record or other technical databases, manipulation, interpretation or routine reporting of data.
  </li>
  <li>
   Understands the design of healthcare documentation systems (Electronic Health Record, Cardiovascular Hemodynamic Systems, Registry Databases).
  </li>
  <li>
   Previous experience reporting to Clinical Reporting Registries (i.e. American College of Cardiology, Society of Thoracic Surgeons, National Surgical Quality Improvement Project), The Joint Commission, Center for Medicare and Medicaid Services, Agency for Healthcare Research and Quality, and Health Regulators required.
  </li>
  <li>
   Ability to express complex analytical and technical information to Executives or to Institute or Department leads.
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  <li>
   Proficient in the use of PCs, spreadsheets and other software applications.
  </li>
  <li>
   Strong oral and written communication skills.
  </li>
 </ul>
 <p>
 </p>
</div>


Clinical Data Abstractor

Caris Life Sciences

<div><p><b>At Caris, we understand that cancer is an ugly word&mdash;a word no one wants to hear, but one that connects us all. That&rsquo;s why we&rsquo;re not just transforming cancer care&mdash;we&rsquo;re changing lives.<br>
</b></p><p></p><p>We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: <i>&ldquo;What would I do if this patient were my mom?&rdquo; </i>That question drives everything we do.<br>
</p><p></p><p>But our mission doesn&rsquo;t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare&mdash;driven by innovation, compassion, and purpose.<br>
</p><p></p><p><b>Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
</b></p><p></p><p><b>Position Summary
</b></p><p>The Clinical Data Coordinator is responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position will ensure the highest standards for clinical data integrity and quality are maintained in alignment with critical research efforts aimed to improve the treatment, health and medical outcomes for oncology patients. Responsible for the collection and review of clinical protocol research data; Interpretation of data (including appropriate source documentation) for entry into computerized databases; Good understanding of data definitions and case report forms and other information related to data collection for clinical research. Must respond to queries in a timely fashion. Schedule on-site visits to perform data review and EDC data entry.
</p><p></p><p><b>Job Responsibilities
</b></p><ul><li><p>Abstract clinical data from subject source documentation.
</p></li><li><p>Enter clinical data into the study specific EDC case report forms.
</p></li><li><p>Clean the clinical data to verify accuracy.
</p></li><li><p>Update the EDC following verification of subject data, including the resolution of data queries.
</p></li><li><p>Track site goals and case report form completion.
</p></li><li><p>Prioritize site cases for analysis.
</p></li><li><p>Maintain study specific documentation.
</p></li><li><p>Perform QC audits of the clinical database.
</p></li><li><p>Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPAA regulations, Site Operating Procedures and ethical standards for the conduct of research clinical trials.
</p></li><li><p>Work closely with onsite team to confirm appropriate consenting is being performed and documented prior to data abstraction.
</p></li><li><p>Maintain to Caris and Site requirements for source document management and request for information.
</p></li><li><p>Act as site designated entry person.
</p></li><li><p>Willingness to travel to multiple investigative sites if required.
</p></li><li><p>Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff.
</p></li></ul><p></p><p><b>Required Qualifications
</b></p><ul><li><p>Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment.
</p></li><li><p>Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations.
</p></li><li><p>Clinical study experience in the field of Oncology.
</p></li><li><p>Strong medical terminology understanding.
</p></li><li><p>Experience in both small and large scale project planning and reporting with strong communication and presentation skills.
</p></li><li><p>Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues.
</p></li><li><p>Experience with EDC systems.
</p></li><li><p>Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use .
</p></li></ul><p></p><p><b>Physical Demands
</b></p><ul><li><p>Must possess ability to sit and/or stand for long periods of time.
</p></li></ul><p></p><p><b>Training
</b></p><ul><li><p>All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
</p></li></ul><p></p><p><b>Other
</b></p><ul><li><p>This position may require occasional evenings and overtime.
</p></li></ul><p></p><p><b>Conditions of Employment: </b>Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions ) and reference verification.
</p><p></p><p>This job description reflects management&rsquo;s assignment of essential functions. Nothing in this job description restricts management&rsquo;s right to assign or reassign duties and responsibilities to this job at any time.<br>
</p><p></p><p>Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.</p></div>

Clinical Data Coordinator I

Renstar Medical Research

<div>
 <strong>
  Description
  <br/>
  <br/>
 </strong>
 Renstar Medical Research is seeking an Associate Research Coordinator to support our clinical trial team. This role provides increased responsibility in participant visit management, study coordination, and protocol execution while working closely with experienced Clinical Research Coordinators and investigators.
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 <br/>
 This position is ideal for Clinical Research Assistants or research professionals who are ready to take the next step toward Clinical Research Coordinator responsibilities.
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 <strong>
  Requirements
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  <br/>
 </strong>
 <strong>
  Key Responsibilities
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  <br/>
 </strong>
 <ul>
  <li>
   Conduct and assist with participant visits in accordance with study protocols
  </li>
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   Coordinate participant scheduling and protocol-required visits, including imaging and other study-related procedures.
  </li>
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   Perform protocol-required clinical procedures and assessments once trained and delegated
  </li>
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   Maintain accurate source documentation and ensure activities are documented according to study requirements
  </li>
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   Coordinate with QC/Data Specialists to resolve data queries and ensure documentation supports study data.
  </li>
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   Communicate with sponsors and CRO representatives regarding protocol procedures when appropriate.
  </li>
  <li>
   Prepare study materials and documentation for participant visits and monitoring visits
  </li>
  <li>
   Support the operational management of assigned studies throughout the study lifecycle.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Clinical research experience preferred (e.g., Clinical Research Assistant or similar role)
  </li>
  <li>
   Healthcare or patient-care experience in a clinical setting
  </li>
  <li>
   Strong understanding of clinical research processes and Good Clinical Practice (GCP) principles
  </li>
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   Strong attention to detail and documentation accuracy
  </li>
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   Ability to work effectively across multidisciplinary clinical research teams
  </li>
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   Strong multitasking and prioritization skills in a multi-trial research environment
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   <br/>
  </li>
 </ul>
 <strong>
  Education
  <br/>
  <br/>
 </strong>
 Associate or bachelor&rsquo;s degree in health sciences, biological sciences, psychology, nursing, or a related field preferred.
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 <br/>
 Equivalent clinical research or healthcare experience may be considered in lieu of formal education.
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 <strong>
  Career Development
  <br/>
  <br/>
 </strong>
 Renstar Medical Research is committed to developing clinical research professionals. This role is part of a structured career pathway:
 <br/>
 <br/>
 Clinical Research Assistant ? Associate Research Coordinator ? Clinical Research Coordinator
</div>


Associate Research Coordinator

The University of Michigan

<p></p><div><div><div><h2 class="jobSectionHeader"><b>How to Apply</b></h2><p>
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.</p><h2 class="jobSectionHeader"><b>
Job Summary</b></h2><p>
This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 175 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.</p><p>
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.</p><h2 class="jobSectionHeader"><b>
Responsibilities*</b></h2><p>
Characteristic Duties and Responsibilities:</p><p>
Independent knowledge, skills, and abilities within all 8 competency domains is expected:</p><ul><li>
Scientific Concepts and Research Design</li><li>
Ethical Participant Safety Considerations</li><li>
Investigational Products Development and Regulation</li><li>
Clinical Study Operations (GCPs)</li><li>
Study and Site Management</li><li>
Data Management and Informatics</li><li>
Leadership and Professionalism</li><li>
Communication and Teamwork</li></ul><p>
This position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.</p><p>
Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Data. Examples of duties a successful candidate in this role will perform:</p><p><b>
Clinical Research Coordinator - Associate</b></p><ul><li>
Demonstrates the ability to document data in accordance with ALCOA-C principles.</li><li>
Explains how to utilize information from the EMR and study databases.</li><li>
Completes complex data collection during study visits.</li><li>
Demonstrates ability to resolve data queries.</li><li>
Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.</li><li>
Schedules, assists with preparation for, and attends study initiations meetings, monitor visits, and audits.</li></ul><p><b>
Clinical Research Coordinator - Technician</b></p><p>
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.</p><ul><li>
Completes simple to moderately complex CRFs.</li><li>
Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC).</li><li>
Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.</li></ul><p><b>
Clinical Research Coordinator - Assistant</b></p><p>
This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.</p><ul><li>
Demonstrates the ability to complete simple data collection during study visits (e.g., basic demographic information).</li><li>
Enters data to complete forms (CRFs) on paper, databases, or EDCs.</li><li>
Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs, as assigned.</li><li>
May administrator minimal risk consents, surveys, and questionnaires.</li><li>
Checks own work and confirms accuracy.</li><li>
Demonstrates ability to perform concomitant medications abstraction.</li><li>
Uses various NCI AE grading scales.</li><li>
Builds patient research study charts.</li><li>
Demonstrates ability to resolve simple queries.</li><li>
Assists in quality control efforts (e.g., review of consents for signatures).</li></ul><h2 class="jobSectionHeader"><b>
Required Qualifications*</b></h2><p><b>
Clinical Research Coordinator - Associate</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.</li><li>
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professional (CCRP) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.</li><li>
Minimum of 2 years directly related experience in clinical research and clinical trials is necessary.</li></ul><p><b>
Clinical Research Coordinator - Technician</b></p><ul><li>
Associate degree in health science or an equivalent combination of related education and experience is necessary.</li><li>
Minimum 1 year directly related experience in clinical research and clinical trials is necessary or an advanced degree in a health-related area such as Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD or minimum 3 years of human subject experience (clinical, lab, or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.</li></ul><p><b>
Clinical Research Coordinator - Assistant</b></p><ul><li>
High School Diploma or GED is necessary.</li></ul><h2 class="jobSectionHeader"><b>
Desired Qualifications*</b></h2><p><b>
Clinical Research Coordinator - Associate</b></p><ul><li>
4+ years of direct related experience.</li></ul><p><b>
Clinical Research Coordinator - Technician</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is desirable.</li><li>
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.</li></ul><p><b>
Clinical Research Coordinator - Assistant</b></p><ul><li>
Associate degree in health science or an equivalent combination of related education and experience is desirable.</li><li>
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.</li></ul><h2 class="jobSectionHeader"><b>
Why Join Michigan Medicine?</b></h2><p>
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.</p><p><b>
What Benefits can you Look Forward to?</b></p><ul>
<li>Excellent medical, dental and vision coverage effective on your very first day</li>
<li>2:1 Match on retirement savings</li></ul><h2 class="jobSectionHeader"><b>
Modes of Work</b></h2><p>
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.</p><h2 class="jobSectionHeader"><b>
Work Schedule</b></h2><p>
Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.</p><h2 class="jobSectionHeader"><b>
Underfill Statement</b></h2><p>
This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.</p><h2 class="jobSectionHeader"><b>
Background Screening</b></h2><p>
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.</p><h2 class="jobSectionHeader"><b>
Application Deadline</b></h2><p>
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.</p><h2 class="jobSectionHeader"><b>
U-M EEO Statement</b></h2><p>
The University of Michigan is an equal employment opportunity employer.</p></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Job Opening ID</b></h3>
<div><p>276036</p>
</div></div><div><h3 class="jobSectionHeader"><b>Working Title</b></h3>
<div><p>Clinical Research Coord Associate/ Technician/ Assistant</p>
</div></div><div><h3 class="jobSectionHeader"><b>Job Title</b></h3>
<div><p>Clinical Research Coord Assoc</p>
</div></div><div><h3 class="jobSectionHeader"><b>Work Location</b></h3>
<div><p>Ann Arbor Campus</p>
</div></div><p>Ann Arbor, MI</p>
<div><h3 class="jobSectionHeader"><b>Modes of Work</b></h3>
<div><p>Hybrid
</p></div></div><div><h3 class="jobSectionHeader"><b>Full/Part Time</b></h3>
<div><p>Full-Time</p>
</div></div><div><h3 class="jobSectionHeader"><b>Regular/Temporary</b></h3>
<div><p>Regular</p>
</div></div><div><h3 class="jobSectionHeader"><b>FLSA Status</b></h3>
<div><p>Nonexempt</p>
</div></div><div><h3 class="jobSectionHeader"><b>Organizational Group</b></h3>
<div><p>Medical School</p>
</div></div><div><h3 class="jobSectionHeader"><b>Department</b></h3>
<div><p>MM O-CTSU Study Coord Data</p>
</div></div><div><h3 class="jobSectionHeader"><b>Posting Begin/End Date</b></h3>
<div><p>4/09/2026 - 4/30/2026</p>
</div></div><div><h3 class="jobSectionHeader"><b>Career Interest</b></h3>
<div><p>Research</p></div></div></div>

Clinical Research Coord Associate/ Technician/ Assistant

Valiance clinical research

<p><b>Job Title:</b> Clinical Data Entry &amp; Data Management Specialist<br/><b>Company:</b> Valiance Clinical Research<br/><b>Location:</b> Valencia<br/><b>Job Type:</b> Full-Time</p><p><b>About Us:</b><br/>Valiance Clinical Research is a modern clinical research organization focused on delivering high-quality, efficient trials through strong data integrity and operational excellence. We partner with sponsors and CROs to support accurate, compliant, and timely study execution.</p><p><b>Position Overview:</b><br/>We are seeking a detail-oriented Clinical Research Data Entry &amp; Data Management Coordinator to support our research team. This role is responsible for accurate and timely data entry, data validation, and maintaining high-quality clinical trial records in compliance with regulatory standards.</p><p><b>Key Responsibilities:</b></p><ul><li>Enter clinical trial data into electronic data capture (EDC) systems</li><li>Review source documents for accuracy and completeness</li><li>Perform data verification and resolve discrepancies/queries</li><li>Maintain organized and audit-ready study records</li><li>Ensure compliance with GCP, HIPAA, and study protocols</li><li>Collaborate with site staff to ensure timely and accurate data reporting</li></ul><p><b>Qualifications:</b></p><ul><li>High school diploma or equivalent required; associate or bachelor&rsquo;s degree preferred</li><li>Previous data entry or administrative experience required (clinical research experience a REQUIRED)</li><li>Strong attention to detail and accuracy</li><li>Familiarity with EDC systems is a REQUIRED</li><li>Proficiency in eSources and CTMS is REQUIRED</li><li>Ability to manage deadlines and prioritize tasks effectively</li></ul><p><b>Why Join Us:</b></p><ul><li>Entry point into the clinical research industry</li><li>Supportive and collaborative work environment</li><li>Opportunities for growth within clinical research</li><li>Competitive compensation and benefits</li></ul><p><b>Apply Today:</b><br/>Submit your resume via Indeed to join Valiance Clinical Research and contribute to high-quality clinical data that drives medical innovation.</p><p>Pay: $22.00 - $25.00 per hour</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Retirement plan</li><li>Vision insurance</li></ul><p>Application Question(s):</p><ul><li>Experience with iMedidata, Veeva, Oracle, iMedNet, and other EDC vendors?</li><li>Experience with eSources?</li></ul><p>Work Location: In person</p>

Clinical Research Data Entry & Data Management Coordinator

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

Polaris Pharmaceuticals Inc.

<div>
 <p>
  <strong>
   Clinical Research Associate
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Location : San Diego, CA (Hybrid 1 day/week)
  </strong>
 </p>
 <p>
  <strong>
   Reports to : Associate Director Clinical Trial Management
  </strong>
 </p>
 <p>
  <strong>
   Job Type : Full Time
  </strong>
 </p>
 <p>
  <strong>
   FLSA : Exempt
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Company Overview
  </strong>
 </p>
 <p>
  Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company&rsquo;s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.
 </p>
 <p>
  Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Summary
  </strong>
 </p>
 <p>
  We are seeking an in-house Clinical Research Associate with oncology experience to independently monitor and manage clinical sites participating in studies with pegargiminase. No travel requirements are anticipated as all monitoring visits will be conducted remotely. Additional responsibilities will include support for the maintenance of monitoring related documents and trackers.
 </p>
 <p>
  <br/>
 </p>
 <p>
  The position will report to the Associate Director Clinical Trial Management and will be hybrid position requiring a minimum of one day per week in the San Diego office.
 </p>
 <p>
  <br/>
 </p>
 <p>
  We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Support study monitoring startup tasks including the development of plans and manuals, training, reviewing, and approving essential documents, facilitating completion of clinical study agreements and shipment of investigation product.
  </li>
  <li>
   Perform clinical monitoring activities to ensure that the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirements
  </li>
  <li>
   Independently conduct monitoring visits to ensure accuracy of data entry with source documentation and perform study drug accountability or manage outsourced CRA performing these activities
  </li>
  <li>
   Review clinical site regulatory documents to ensure completeness and retrieve documents for the Trial Master File
  </li>
  <li>
   Maintain the internal Trial Master File and periodically review
  </li>
  <li>
   Support the preparation of project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries as required
  </li>
  <li>
   Monitor and track clinical research progress and provide status update reports
  </li>
  <li>
   Liaise with clinical sites and provide guidance on site/study issues
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Required Qualifications
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree, preferably in science or healthcare
  </li>
  <li>
   Demonstrated clinical research experience with a minimum of 2 years monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO, or in a hospital setting with experience in oncology
  </li>
  <li>
   Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines
  </li>
  <li>
   Excellent written and verbal communication skills
  </li>
  <li>
   Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint
  </li>
  <li>
   Ability to work independently and prioritize multiple projects in a fast-paced environment.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Physical / Work Environment
  </strong>
 </p>
 <ul>
  <li>
   This role is mainly a desk role requiring proper ergonomics.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Salary Range
  </strong>
 </p>
 <ul>
  <li>
   Annual base salary: $80,000 to $110,000
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Equal Employment Opportunity Statement
  </strong>
 </p>
 <p>
  Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.
 </p>
 <p>
 </p>
</div>


Clinical Research Associate

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