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Clinical Data Monitor I

Caris Life Sciences
  • Texas
    30+ days ago

    Job Description

    At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.

     

    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: “What would I do if this patient were my mom?” That question drives everything we do.

     

    But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose.

     

    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.

    Job Description

    Position Summary 

    The Clinical Data Monitor is responsible for clinical data management activities for the Caris sponsored and collaborating protocols and projects.  This role ensures the highest standards of data integrity and quality in support of critical research efforts to improve treatment, health, and medical outcomes for oncology patients. The Clinical Data Monitor I provides support to both external and internal research coordinators in patient enrollment, data collection, and data query resolution. Responsibilities include oversight and management of clinical investigative sites in accordance with Federal Code of Regulations, Good Clinical Practices (GCP), Good Registry Practices (GRP), ICH Guidelines, local regulations, and applicable Compliance and Sponsor SOPs. 

    Job Responsibilities 

    • Maintains proficient knowledge of Electronic Data Capture (EDC) systems to support training, change proposals, and user acceptance testing.

    • Establish and maintain strong working relationships with site data and regulatory coordinators.

    • Perform quality control review of submitted Case Report Forms (CRFs), including source document verification and issuance of data queries.

    • Serve as an evaluator for internal Clinical Research Coordinators in training and provide detailed, constructive feedback.

    • Maintain regulatory documentation for all assigned sites and study staff.

    • Create and manage site records within the EDC for newly onboarded sites.

    • Conduct quality control audits of the clinical database.

    • Ensure compliance with GCP guidelines, FDA, Institutional Review Board (IRB), HIPAA regulations, site operating procedures, and ethical standards for the conduct of clinical research.

    • Collaborate closely with onsite teams to confirm appropriate consenting is completed and documented prior to data abstraction.

    • Communicate effectively with research teams, investigators, study sponsors, and ancillary staff.

    Required Qualifications 

    • Requires 3-5 years of experience in data collection activities within a GCP regulated clinical research environment.

    • Proficient in Microsoft Office Suite

    • Experience working with Electronic Data Capture (EDC) systems.

    • Clinical study experience in oncology.

    • Strong understanding of medical terminology.

    • Ability to work independently and make sound decisions.

    • Strong organizational skills with the ability to prioritize, meet deadlines, and manage multiple projects simultaneously.

    • Demonstrated ability to build trust with site personnel and communicate effectively with diverse stakeholders.

    • High attention to detail with a passion for contributing to meaningful research outcomes for patients.

    • Strong problem solving skills and the ability to deliver practical solutions.

    • Excellent written and verbal communication skills in English.

    • Professional demeanor with positive, collaborative interactions with internal and external partners.

    • Ability to propose, implement, and evaluate appropriate resolutions to issues. 

    Preferred Qualifications 

    • Bachelor’s degree preferred

    • Research Coordinator certification (SoCRA, ACRP)

    • Working knowledge of human anatomy.

    Physical Demands 

    • Ability to sit and or stand for extended periods of time.

    • Ability to lift routine office supplies and operate standard office equipment.

    Training 

    All job specific, safety, and compliance training will be assigned based on the responsibilities associated with this position, including but not limited to:

    • Good Clinical Practices (GCP)

    • Human Subject Protection (HSP) Training

    • SEER Primary Site Training

    • Multiple Primary and Histology Rules

    • AJCC Staging 

    Other 

    • At times, may be required to work weekends/holidays.

    Annual Hiring Range

    $74,000 - $84,000

    Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer.

    Description of Benefits

    • Highly competitive and inclusive medical, dental and vision coverage options
    • Health Savings Account for medical expenses and dependent care expenses
    • Flexible Spending Account to pay for certain out-of-pocket expenses
    • Paid time off, including: vacation, sick time and holidays
    • 401k match and Financial Planning tools
    • LTD and STD insurance coverages, as well as voluntary benefit options
    • Employee Assistance Program
    • Pet Insurance
    • Legal Assistance
    • Tuition Assistance

    Conditions of Employment:  Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

    This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

     

    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.

    Numbers & Facts

    LocationTexas
    IndustryBiotechnology/Pharmaceuticals
    Company Size100 to 499 employees
    Year Founded1996
    Websitehttp://www.carislifesciences.com/

    About Company

    Caris Life Sciences® is a leading biotechnology company focused on fulfilling the promise of precision medicine through quality and innovation. Caris Molecular Intelligence®, the company’s healthcare information and comprehensive tumor profiling service with more than 70,000 patients profiled, provides oncologists with the most clinically actionable treatment options available to personalize cancer care today. Using a variety of advanced profiling technologies to assess relevant biological changes in each patient’s tumor, Caris Molecular Intelligence connects biomarker data generated from a tumor with biomarker-drug associations supported by evidence in the relevant clinical literature. The company is also developing its ADAPT Biotargeting System™ technology, a revolutionary and proprietary blood-based platform for the development of novel therapeutics, drug delivery and drug target identification. The platform is also being developed for diagnosis, prognosis, and theranosis of cancer and other complex diseases.

    Caris also maintains the Center of Excellence Network for Precision Medicine (“COE Network”) which was established to promote the appropriate study and use of molecular profiling in the diagnosis and treatment of cancer with leading cancer centers in the United States. Headquartered in the Dallas-Fort Worth Metroplex, Caris Life Sciences offers services throughout Europe, the U.S., Australia and other international markets.

    Skills

    • Acceptance Testingunmatched
    • Artificial Intelligence (AI)unmatched
    • Auditingunmatched
    • Background Investigationunmatched
    • Biologyunmatched
    • Booking Arrestsunmatched
    • Cancerunmatched
    • Change Requests/Ordersunmatched
    • Clinical Dataunmatched
    • Clinical Data Collectionunmatched
    • Clinical Data Managementunmatched
    • Clinical Monitoringunmatched
    • Clinical Researchunmatched
    • Communication Skillsunmatched
    • DNAunmatched
    • Data Collectionunmatched
    • Data Qualityunmatched
    • Detail Orientedunmatched
    • Diseaseunmatched
    • Electronic Data Capture (EDC)unmatched
    • English Languageunmatched
    • Establish Prioritiesunmatched
    • FDA (Food and Drug Administration)unmatched
    • Financial Planningunmatched
    • GCP (Good Clinical Practices)unmatched
    • HIPAA (Health Insurance Portability and Accountability Act)unmatched
    • Healthcareunmatched
    • Human Anatomyunmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • Insuranceunmatched
    • Legalunmatched
    • Maintain Complianceunmatched
    • Medical Terminologyunmatched
    • Medicineunmatched
    • Multitaskingunmatched
    • Office Equipmentunmatched
    • Oncologyunmatched
    • Operations Processesunmatched
    • Organizational Skillsunmatched
    • Physical Demandsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Project/Program Managementunmatched
    • Quality Controlunmatched
    • Records Managementunmatched
    • Reference Verificationunmatched
    • Regulationsunmatched
    • Research Skillsunmatched
    • Society of Clinical Research Associates (SoCRA)unmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Training/Teachingunmatched
    • Tuition Feesunmatched
    • Writing Skillsunmatched

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