senior clinical research scientist

Global Channel Management, Inc

Senior Food Scientist needs 5 years experience<BR>Senior Food Scientist requires:<BR>o Scientist<BR>o Food Science<BR>o Nutrition<BR>o Product development experience from concept to commercialization in nutrition<BR>o Food, beverage, supplement, nutraceutical, or biotech industries.<BR>Senior Food Scientist duties:<BR>o Develop and optimize nutritional beverage and powder formulations that meet nutritional, sensory, and stability goals.<BR>o Partner with Medical Nutrition, Marketing, and Sales to align product design with business and patient needs.<BR>o Research and evaluate new ingredients and explore new medical nutrition opportunities.<BR>o Support leadership with technical and scientific expertise for product and clinical development.<BR>o Build vendor relationships to source ingredients that meet product requirements.<BR>o Present company research at scientific meetings and conferences.<BR>o Ensure strong intellectual property protection for new products and processes.<BR>o Follow all GMP, food safety, and workplace safety policies.<img src="https://www.jobg8.com/Tracking.aspx?TyfogLXvGD0gntbDyptVij%2fvYD8kjE3Vv" width="0" height="0" />

Senior Food Scientist n

Jupiter Life Science Consulting

<div>
 Clinical Research Scientist
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 <br/>
 The Clinical Research Scientist will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.
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 <br/>
 <strong>
  About Red Nucleus
  <br/>
  <br/>
 </strong>
 Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services (commercial, market access, medical affairs), and medical communications solutions for the life sciences industry. Our global team is composed of nearly 1,000 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.
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 <br/>
 At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a &ldquo;Great Place to Work".
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 <strong>
  Responsibilities Include
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 </strong>
 <ul>
  <li>
   Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&amp;D, Marketing) to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to align clinical evidence strategies, document / track decisions and risks, and write PMCF Plans.
  </li>
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   Develop and write high quality Post-market Clinical Follow-up (PMCF) plans and reports with minimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where needed.
  </li>
  <li>
   Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).
  </li>
  <li>
   Where required, foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection. Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
  </li>
  <li>
   Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
  </li>
  <li>
   Support clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&amp;D and Marketing to drive support of the clinical and regulatory strategy, communicate evidence needs.
  </li>
  <li>
   Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
  </li>
  <li>
   Develop a strong understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
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   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
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  <br/>
 </strong>
 <ul>
  <li>
   A Master&rsquo;s degree in Biological Science or related discipline, with a minimum of 4 years&rsquo; experience in the medical device industry or healthcare field is required
  </li>
  <li>
   Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports strongly preferred.
  </li>
  <li>
   Clinical expertise in the medical device sector
  </li>
  <li>
   Proven experience in conducting clinical studies, registries particularly in the field of orthopaedics
  </li>
  <li>
   Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
  </li>
  <li>
   Excellent communication skills, including effective interaction with healthcare professionals (HCPs), hospital staff etc.
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   <br/>
  </li>
 </ul>
</div>


Clinical Research Scientist (Device, Ortho)

ICON plc

<div>
 CDC II _ Office Based _ Hybrid
 <br/>
 <br/>
 ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
 <br/>
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 We are currently seeking a Clinical Data Coordinator II to join our diverse and dynamic team. As a Clinical Data Coordinator II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.
 <br/>
 <br/>
 <strong>
  What You Will Be Doing
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  <br/>
 </strong>
 <ul>
  <li>
   Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures.
  </li>
  <li>
   Manage clinical and third-party data reconciliation based on edit specifications and data review plans.
  </li>
  <li>
   Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management.
  </li>
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   Address data related questions and recommend potential solutions.
  </li>
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   Identify root cause to systematically resolve data issues.
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  </li>
 </ul>
 <strong>
  Your profile
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 </strong>
 <ul>
  <li>
   Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.
  </li>
  <li>
   Intermediate kNwledge of clinical data management within the pharmaceutical or biotechNlogy industry.
  </li>
  <li>
   Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
  </li>
  <li>
   Strong attention to detail and the ability to work effectively in a fast-paced environment.
  </li>
  <li>
   Excellent communication skills and the ability to collaborate with cross-functional teams.
  </li>
  <li>
   KNwledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
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  </li>
 </ul>
 <strong>
  What ICON Can Offer You
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  <br/>
 </strong>
 Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
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 In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
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 <strong>
  Our Benefits Examples Include
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 </strong>
 <ul>
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   Various annual leave entitlements
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   A range of health insurance offerings to suit you and your family&rsquo;s needs.
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   Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
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  <li>
   Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
  </li>
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   Life assurance
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   Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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  </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
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 <br/>
 At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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 If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
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 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.
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 Are you a current ICON Employee? Please click here to apply
</div>


Senior CDC/CDC II

Vertex Pharmaceuticals

<div><p><b>Job Description
</b></p><p><b>General Summary:
</b></p><p></p><p>The Biomarkers Senior Principal Research Scientist (Associate Director) is an independent leader with advanced scientific knowledge and expertise in biomarker development who develops and implements the clinical biomarker strategy for one or more programs and implements the biomarker plan during clinical development with no/minimal guidance. Experience in authoring and supporting regulatory filings and applicable areas of these filings is required. The incumbent is an expert in the field of assay development and validation and works with a team and several external CROs to ensure fit-for-purpose validation of biomarker assays. The incumbent candidate is a specialized technical expert in specific areas in biomarker development (e.g. CDx, immunoassays, genomic assays, flow assays, etc.) who can lead specific workstreams and capabilities within the group and mentor others within the team.
</p><p></p><p><b>Key Duties and Responsibilities:
</b></p><ul><li>Develops and aligns the biomarker strategy cross-functionally .
</li><li>Provides expert oversight of the development, validation, and timely implementation of fit-for-purpose biomarker assays for clinical phase program in accordance with regulatory guidance, along with providing supportive written documentation
</li><li>Serves as key point of contact for internal and external stakeholders regarding assay design requirements, e.g. patient selection, target engagement, pharmacodynamic, and mechanism of action biomarkers.
</li><li>Responsible for assay activities performed at external vendors and providing guidance requirements for developing and utilizing assays in GCLP settings.
</li><li>Establishes strong working relationships with key diagnostics vendors and CROs that will employ assays both developed internally at Vertex and at an external vendor.
</li><li>Represents biomarker at key cross-functional teams and responsible for all key biomarker deliverables for the program(s).
</li><li>Presents and communicates biomarker data and strategy at cross-functional team meetings and to senior management.
</li><li>Represents Vertex at external conferences, meetings, and discussions to present topics on biomarker development and validation.
</li><li>Leads specific workstreams and capabilities as a specialized technical expert and develops new expertise within the group to build the biomarker capability within the team.
</li><li>May resolve complex problems with wide-reaching implications for the organizational function.
</li></ul><p></p><p><b>Knowledge and Skills:
</b></p><ul><li>At least 9+ years of experience and scientific achievement in biotech / pharmaceutical drug discovery and development
</li><li>Experience in translating disease biology and translational science data of therapeutic agents into clinical biomarkers for patient selection and monitoring
</li><li>Expertise in standard immunological assays; strong foundation in assay validation under regulatory conditions (GCLP, GLP, IVD)
</li><li>Experience in selection and oversight of clinical trial biomarker assay vendors
</li><li>Must have clinical trial experience; global late-stage trial experience preferred
</li></ul><p></p><p><b>Education and Experience:
</b></p><ul><li>Ph.D. (or equivalent degree) in immunology or a relevant scientific field and 6-8 years of relevant experience
</li><li>Master's Degree (or equivalent degree) and 9+ years of relevant employment experience, or
</li><li>Bachelor's Degree (or equivalent degree) and 12+ years of relevant employment experience
</li></ul><p>#LI-KM4
</p><p></p><p><b>Pay Range:
</b></p>$154,600 - $231,800
<p></p><p><b>Disclosure Statement:
</b></p><div><div><div><div><p>The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
</p><p></p><p>At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
</p></div></div></div></div><p></p><p><b>Flex Designation:
</b></p>On-Site Designated
<p></p><p><b>Flex Eligibility Status:
</b></p><div><p>In this <b>On-Site </b>designated role, you will work <b>five days per week on-site </b>with ad hoc flexibility.
</p></div><div><p>Note: The Flex status for this position is subject to Vertex&rsquo;s Policy on Flex @ Vertex Program and may be changed at any time.
</p></div><p></p><p><b>Company Information
</b></p><p>Vertex is a global biotechnology company that invests in scientific innovation.
</p><p></p><p>Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
</p><p></p><p>Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com</p></div>

Senior Principal Research Scientist, Biomarkers Lead (Immunology)

Children's Hospital Colorado

<div><h2 class="jobSectionHeader"><b>Job Overview</b></h2>
<div>
<div><div><div><p>Senior Clinical Research Coordinator Neurology</p><p>
The Clinical Research Coordinator Senior is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. This position will support the Neurogenetics team within the CCHRI, performing a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Facilitates the accomplishment of research programs and/or study goals. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under minimal supervision.</p><p><b>
Additional Information:</b></p><p>
Department: CCHRI - Operations<br>
Hours: 40 hours/week<br>
Shift: M-F, 8-4:30. This position has the flexibility to be a hybrid role.<br>
<br>
<b>Duties &amp; Responsibilities</b></p><ul><li>
Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.</li><li>
Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.</li><li>
Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.</li><li>
Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements. Assists with the development of proposals or protocols. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.</li><li>
Human Subject Research Protection - Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Serves as a resource and trainer for issues related to professional guidelines and code of ethics. Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution.</li><li>
Leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Provides significant contribution and influence upon research work, activities and/or productivity of study teams. Leads a committee or task force under direction of a supervisor. Leads scientific or programmatic presentations. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. Implements with leadership team on the operational elements needed for the conduct of clinical and translational programs and/or studies.</li><li>
Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data and assists management with resolution. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and develops and implements retraining as appropriate. Adheres to and oversees the development and assessment of quality assurance processes. Identifies issues related to operational efficiency and shares results with team members and management. Recognizes when data agreements or special regulatory requirements are necessary and acts as a resource and mentor to determine when special contracts are necessary and escalates to stakeholders. Develops systems and/or frameworks for quality assurance processes in collaboration with leadership.</li><li>
Participates in and provides oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Comprehensive understanding of institutional process for the development of budgets. Proactively identify gap deficits and escalating.</li><li>
Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design.</li></ul><p><b>
Minimum Qualifications</b></p><ul><li><b>
Education: </b>Bachelor&rsquo;s degree in a related field is required.</li><li><b>
Experience:</b> Minimum of three (3) years of clinical, clinical support, and or clinical research related experience is required.</li><li><b>
Equivalency:</b> Associate degree in a related field with (5) five years of clinical related experience may be considered in lieu of minimum education requirement.</li></ul><p><b><br>
Salary Information</b><br>
Pay is dependent on applicant's relevant experience.<br>
<br>
Hourly Range: $25.95 to $38.93<br>
<br>
<b>Benefits Information</b><br>
Here, you matter. As a Children&rsquo;s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.</p><p>
As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.</p><p>
Children&rsquo;s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.<br>
<br>
<b>EEO Statement</b><br>
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.<br>
<br>
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.</p></div></div></div></div></div>

Senior Clinical Research Coordinator Neurology

University of Colorado

<div></div><div><div>University Staff<div>
</div></div><div><b>
Description</b><div></div><div><b><br>
University of Colorado Anschutz Medical Campus</b></div><div><b>
Department: Emergency Medicine</b></div><div><b>
Job Title: Research Services Clinical Sciences Professional (Senior or Principal)</b></div><p><b>
Position #: 00841368 &ndash; Requisition #: </b><b>38110</b></p><p>
</p><div><div><p><b>Job Summary:</b></p><div><p><br>
The Department of Emergency Medicine and the principal investigator, Dr. Elizabeth Goldberg, MD, ScM,, is seeking applications for a <b>Clinical Science Professional (Open Rank: Senior-Principal)</b>. This is a full-time University staff position to support ongoing grant-funded studies focused on geriatric emergency medicine, injury prevention, and digital health. Funding support comes from multi-year project grants from Health and Human Services and the National Institutes of Health. This research team focuses on observational studies and interventional trials related to emergency care. The candidate will play a key role in a new Health and Human Services grant to expand the reach of evidence-based fall prevention programs throughout Colorado, in collaboration with the Colorado Department of Human Services and the Areas on Aging. The candidate will assume the role of <b>Clinical Science Professional</b> within a highly collaborative and exciting multi-disciplinary team.</p><p><b>
</b></p><p><b>Key Responsibilities:</b></p><ul><li><p>
Assist with and oversee the day to day operations of clinical trials and studies, and act as primary coordinator, including team meetings, steering committee engagement, collaboration with the health system, institutional review board and university research infrastructure</p></li><li><p>
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies, and perform study related processes, procedures, and assessments as defined in study protocols and in compliance with regulating bodies</p></li><li><p>
Assist with developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs)</p></li><li><p>
Conduct standard research activities such as performing literature searches and creating annotated bibliographies, preparing and administering data collection tools, conducting qualitative coding and analysis, and contributing to manuscripts and presentations. <i>Principal Professional level: act as a Subject Matter Expert and authority in the area(s) of community engagement, data science, clinical informatics systems (e.g. EMR or EHR, Epic, etc) or other relevant areas</i></p></li></ul><p><b>
Senior Professional and all the above:</b></p><ul><li><p>
Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies</p></li><li><p>
Assist with identifying issues related to operational efficiency and shares results with leadership</p></li><li><p>
Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention</p></li><li><p>
Serve as a resource and participate in study initiation and close out duties</p></li></ul><p><b>
Principal professional and all the above:</b></p><ul><li><p>
Coordinate and administer patient care in compliance with protocol requirements</p></li><li><p>
Disburse investigation drug and provide patient education regarding administration</p></li><li><p>
Oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team</p></li></ul><p><b>
Additional Duties &amp; Responsibilities</b></p><ul><li><p>
Manage and conduct moderately complex research activities that are part of larger project from initiation to close.</p></li><li><p>
Create complex data management and tracking tools (REDCap, ACCESS, Excel) to support tracking of project/recruitment activities.</p></li><li><p>
Oversee student worker(s) or junior research assistants as it relates to a specific project.</p></li><li><p>
Travel to study sites including fall prevention programs and referral partner sites (clinical offices and hospitals)</p></li><li><p>
Participate in instrument creation and/or analytical structures as appropriate to the project.</p></li><li><p>
Participate in tactical and strategic program/project development and planning.</p></li><li><p>
Collect study data via complex patient visits, surveys, observations or focus groups. Provide leadership in data collection to other research assistants and students.</p></li><li><div>
Carry out straightforward data analysis (e.g., summary data, histograms) and have basic skills in interpretation of descriptive statistics.</div></li><li><div>
Leverage creative problem-solving skills to ensure high data quality from a team of national data collectors</div></li><li><p>
Participate in audits, monitoring visits, and quality control checks of data collection, equipment maintenance, and study procedures.</p></li><li><p>
Help develop study findings for presentation to team and external audiences.</p></li><li><p>
May lead publication development (abstract/manuscript)</p></li><li><p>
Help with budget management/tracking (under direction of PM/PI)</p></li><li><p>
Lead manuscript preparation for publication or presentation in scientific forums.</p></li><li><p>
Work with members of the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.</p></li><li><p>
Manage study participant incentive program.</p></li><li><p>
Other duties as assigned.</p></li></ul><p><br>
</p></div></div><br>
<div><p><b>Work Location:</b></p><div><p><br>
Onsite &ndash; this role is expected to work onsite and is in Aurora, CO.</p><p>
</p><p>The job is predominantly in-person and duties will be performed in the U.S. from office buildings on the University of Colorado Anschutz Medical Campus in Aurora, CO. This position will exercise building independence and work under the supervision of the PI and project coordinator to assist the team to conduct clinically relevant research.</p><p><br>
</p></div></div><br>
<div><p><b>Why Join Us:</b></p><div><p><br>
The Department of Emergency Medicine at the University of Colorado School of Medicine is dedicated to delivering superlative patient care, providing an environment where training and education thrive and innovation and discovery are fostered.</p><p>
</p><p>The Department of Emergency Medicine is based at the Anschutz Medical Campus in Aurora Colorado. The campus is a state of the art medical campus home to the University of Colorado Schools of Medicine, Nursing, Dentistry, Pharmacy, the Colorado School of Public Health; as well as the University of Colorado Hospital and Children's Hospital Colorado both of which serve as major training sites for the Denver Health Residency in Emergency Medicine.</p><p>
</p><p><b>Why work for the University?</b></p><p>
</p><p>We have AMAZING benefits and offer<b> </b>exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:</p><p>
</p><ul><li><div>Medical: Multiple plan options</div></li><li><div>
Dental: Multiple plan options</div></li><li><div>
Additional Insurance: Disability, Life, Vision</div></li><li><div>
Retirement 401(a) Plan: Employer contributes 10% of your gross pay</div></li><li><div>
Paid Time Off: Accruals over the year</div></li><li><div>
Vacation Days: 22/year (maximum accrual 352 hours)</div></li><li><div>
Sick Days: 15/year (unlimited maximum accrual)</div></li><li><div>
Holiday Days: 10/year</div></li><li><div>
Tuition Benefit: Employees have access to this benefit on all CU campuses</div></li><li><div>
ECO Pass: Reduced rate RTD Bus and light rail service</div></li></ul><p>
</p><p>There are many additional perks &amp; programs with the CU Advantage.</p><p><br>
</p></div></div><br>
<div><p><b>Qualifications:</b></p><div><p><b><br>
Minimum Qualifications:</b></p><p><b><i>
Senior Professional:</i></b></p><ul><li><div>
Bachelor&rsquo;s degree in any field</div><ul><li><div>
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor&rsquo;s degree on a year for year basis</div></li></ul></li><li><div>
Two (2) years clinical research or related experience</div></li></ul><div>
</div><p><b><i>Principal Professional</i></b></p><ul><li><p>
Bachelor&rsquo;s degree in any field</p><ul><li><p>
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor&rsquo;s degree on a year for year basis</p></li></ul></li><li><p>
Three (3) years clinical research or related experience</p></li></ul><p><i>
</i></p><p><i>Applicants must meet minimum qualifications at the time of hire.</i></p><p><b>
</b></p><p><b>Preferred Qualifications:</b></p><p><b><i>
Senior Professional:</i></b></p><ul><li><p>
Bachelor&rsquo;s degree in science or health related field</p></li><li><p>
Three (3) years of clinical research or related experience</p></li><li><p>
Experience with clinical informatics systems (e.g. EMR or EHR, Epic, etc)</p></li><li><p>
Experience in customer discovery, stakeholder or community engagement, or related work</p></li></ul><p>
</p><p><b><i>Principal Professional</i></b></p><ul><li><p>
Bachelor&rsquo;s degree in science or health related field</p></li><li><p>
Master&rsquo;s degree in data science, public health, or a research-related discipline</p></li><li><p>
Four (4) years of clinical research or related experience</p></li><li><p>
Experience with clinical informatics systems (e.g. EMR or EHR, Epic, etc)</p></li><li><p>
Experience in customer discovery, stakeholder or community engagement, or related work</p></li></ul><p><b>
</b></p><p><b>Knowledge, Skills and Abilities:</b></p><ul><li><div>
Knowledge and understanding (principal professional level: advanced knowledge and understanding) of federal regulations and Good Clinical Practice (GCP)</div></li><li><p>
Ability to communicate effectively, both in writing and orally</p></li><li><p>
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution</p></li><li><p>
Outstanding customer service skills</p></li><li><p>
Familiarity with medical/research terminology</p></li><li><p>
Ability to understand and interpret medical terminology and medical charts</p></li><li><p>
Excellent organizational, analytical and interpersonal skills</p></li><li><p>
Ability to think creatively, adapt quickly and work independently</p></li><li><p>
Excellent team player</p></li><li><p>
Enjoys working with human research subjects</p></li><li><p>
Self-starter with a desire to improve human health through research</p></li><li><p>
High Level Skills with Computer-Based Tools (Word, Outlook, PowerPoint, Etc.)</p></li><li><p>
Principal professional level: expert level knowledge of community engagement, data science, clinical informatics systems (e.g. EMR or EHR, Epic, etc) or other relevant areas</p></li></ul><p><br>
</p></div></div><br>
<div><p><b>How to Apply:</b></p><div><p><br>
For full consideration, please submit the following document(s):</p><p>
1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position</p><p>
2. Curriculum vitae / Resume</p><p>
3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address</p><div>
Questions should be directed to: Amy Wayne, amy.wayne@cuanschutz.edu</div><p><br>
</p></div></div><br>
<div><p><b>Screening of Applications Begins:</b></p><div><p><br>
Immediately and continues until position is filled. For best consideration, apply by (11/7/2025).</p><p><br>
</p></div></div><br>
<p></p><div><p><b>Anticipated Pay Range:</b></p><div><p><br>
The starting salary range (<i>or hiring range</i>) for this position has been established as <b>HIRING RANGE:</b></p><p><b>
Senior: $56,995 - $72,498</b><br>
<b>Principal: $65,545 - $83,373</b></p><p>
The above salary range (<i>or hiring range</i>) represents the University&rsquo;s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.</p><p>
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.</p><p>
Total Compensation Calculator</p><p><br>
</p></div></div><br>
<div><div><p><b>Equal Employment Opportunity Statement:</b></p><p><br>
</p></div><p></p><div><p>CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.</p><p><br>
</p></div></div><br>
<div><p><b>ADA Statement:</b></p><div><p><br>
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.</p><p><br>
</p></div></div><br>
<div><p><b>Background Check Statement:</b></p><div><p><br>
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.</p><p><br>
</p></div></div><br>
<div><p><b>Vaccination Statement:</b></p><div><p><br>
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.</p></div></div></div></div><p></p><div><div><br>
</div><div>
</div><b>Application Materials Required</b><b>:</b> Cover Letter, Resume/CV, List of References<br>
<div></div>
<div>
</div></div><div><b>Job Category</b><b>:</b> Research Services<div>
</div></div><div><b>
Primary Location</b><b>:</b> Aurora<div>
</div></div><div><b>
Department</b><b>:</b> U0001 - Anschutz Med Campus or Denver - 20353 - SOM-EM MED CLINICAL<div>
</div></div><div><b>
Schedule</b><b>:</b> Full-time<div>
</div></div><div><b>
Posting Date</b><b>:</b> Oct 24, 2025<div>
</div></div><div><b>
Unposting Date</b><b>:</b> Ongoing<div>
</div></div><div><b>
Posting Contact Name</b><b>:</b> Amy Wayne<div>
</div></div><div><b>
Posting Contact Email</b><b>:</b> amy.wayne@cuanschutz.edu<div>
</div></div><div><b>
Position Number</b><b>:</b> 00841368</div></div>

Research Services Clinical Sciences Professional (Senior or Principal)

The University of Chicago

<div><div>Department</div>
BSD CCC - Network Oncology Research Support<div><br>
About the Department</div>
The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant funds ten Shared Resources. The Comprehensive Cancer Center comprises over 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management, and community outreach.<br>
<br>
UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC's commitment to translating basic research findings to the clinic through proof-of-principle and early-phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.<div><br>
Job Summary</div>
The Sr. Clinical Research Technician provides support to the faculty of the Section of Hematology/Oncology within the Biological Sciences Division. The Sr. CRT will be involved in multiple research trial types, including multi-center cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-center trials designed, implemented, and coordinated within the Section.<br>
<br>
The job performs routine assignments related to the documentation and reporting of basic clinical studies. Supports decisions that impact clinical research conducted across the University.<div></div><div>
Responsibilities</div><ul><li><div>
Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.</div></li><li><div>
Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.</div></li><li><div>
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.</div></li><li><div>
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.</div></li><li><div>
Prepares and maintains protocol submissions and revisions.</div></li><li><div>
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.</div></li><li><div>
Performs assessments at visits and monitors for adverse events.</div></li><li><div>
Organizes and attends site visits from sponsors and other relevant study meetings.</div></li><li><div>
May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.</div></li><li><div>
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.</div></li><li><div>
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.</div></li><li><div>
Performs all tasks in complex clinical studies.</div></li><li><div>
Performs various administrative and operational tasks under moderate supervision. Acts as a resource on the basics of clinical research and related aspects of clinical study for other clinical research staff.</div></li><li><div>
Participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Accountable for problem solving on assigned clinical research studies.</div></li><li><div>
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.</div></li><li><div>
Performs other related work as needed.</div></li></ul><div><br>
Minimum Qualifications</div><div>
Education:</div>
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).<div><br>
Work Experience:</div>
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.<div><br>
Certifications:</div><div>
-</div><div></div><div>
Preferred Qualifications</div><div></div><div>
Experience:</div><ul><li><div>
Knowledge of medical terminology/environment.</div></li><li><div>
Relevant experience greater than 2 years.</div></li></ul><div></div><div>
Preferred Competencies</div><ul><li><div>
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.</div></li><li><div>
Strong organizational skills.</div></li><li><div>
Excellent interpersonal skills.</div></li><li><div>
Strong data management skills and attention to detail.</div></li><li><div>
Knowledge of the Microsoft Suite, including Outlook.</div></li><li><div>
Ability to understand complex documents (e.g., clinical trials).</div></li><li><div>
Ability to handle competing demands with diplomacy and enthusiasm.</div></li><li><div>
Ability to absorb large amounts of information quickly.</div></li><li><div>
Adaptability to changing working situations and work assignments.</div></li></ul><div></div><div>
Working Conditions</div><ul><li><div>
Ability to navigate the UChicago Campus as required by the Position.</div></li><li><div>
Hybrid position with the majority of work being done in-person/ on-site.</div></li></ul><div></div><div>
Application Documents</div><ul><li><div>
Resume (required)</div></li><li><div>
Cover letter (preferred)</div></li></ul><div><div><div><div><div><div><div><div><br>
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.</div></div></div></div></div></div></div></div><div><br>
Job Family</div>
Research<div><br>
Role Impact</div>
Individual Contributor<div><br>
Scheduled Weekly Hours</div>
40<div><br>
Drug Test Required</div>
Yes<div><br>
Health Screen Required</div>
Yes<div><br>
Motor Vehicle Record Inquiry Required</div>
No<div><br>
Pay Rate Type</div>
Hourly<div><br>
<br>
FLSA Status</div>
Non-Exempt<div><br>
<br>
Pay Range</div>
$26.44 - $31.25<div>
The included pay rate or range represents the University&rsquo;s good faith estimate of the possible compensation offer for this role at the time of posting.</div><div><br>
Benefits Eligible</div>
Yes<div>
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the<div> </div><div>Benefits Guidebook</div><div>.</div></div><div><br>
Posting Statement</div><div>
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the <div>University's Notice of Nondiscrimination.</div></div><div></div><div><br>
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via <div>Applicant Inquiry Form.</div></div><div></div><div><br>
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.</div><div></div><div><br>
The University of Chicago's Annual Security &amp; Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: <div>http://securityreport.uchicago.edu</div>. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.</div></div>

Sr. Clinical Research Technician

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