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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.
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.