**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.**
**Position Summary**
The Global Companion Diagnostics Specialist is a key contributor in the Translational Science team responsible for supporting companion diagnostic and in vitro diagnostic product development lifecycle strategies to support global marketing authorizations. This includes clinical programs with focused attention on Design Controls and Good Clinical Practices for clinical performance studies. The Global Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs and other study stakeholders to coordinate study-related activities that are tailored to specific marketing applications. Additional responsibilities include creating study-specific and departmental documentation including but not limited to SOPs, templates, forms, plans, protocols and reports through close collaboration with the appropriate cross-functional teams. The Global Companion Diagnostics Specialist will support clinical study compliance through creation and maintenance of trial master files, study tracking and leading meetings with the study personnel.
**Job Responsibilities**
+ Support, manage and/or coordinate IVD/CDx clinical study activities.
+ Clinical study representative for project and study teams.
+ Facilitate internal and external clinical study preparation and planning meetings.
+ Collaborate and communicate with study personnel and stakeholders.
+ Ensure study protocol, GCP, regulatory and SOP compliance.
+ Participate in site assessment, selection, qualification, initiation and closeout processes.
+ Provide clinical study site oversight.
+ Real-time escalation of clinical studies risks and issues to management.
+ Create and maintain trial master files.
+ Contribute to and/or lead process improvements.
+ Socialize regulatory requirements and standards (e.g., FDA, ICH GCP, ISO 20916, IVDR, MDCG) with cross-functional teams and study personnel.
+ Accepts other duties as assigned.
**Required Qualifications**
+ Minimum BS Degree in a scientific discipline with 3+ years of experience in IVD clinical studies.
+ Understanding of Good Clinical Practices (GCP) and other relevant regulatory requirements
+ Scientific writing experience (e.g., peer-reviewed publications, SOPs, etc.).
+ Must be tolerant to change, ready to take on new challenges and open to learning in a dynamic environment.
**Preferred Qualifications**
+ Master's Degree in a scientific discipline with 3+ years of experience in IVD clinical studies.
+ Knowledge of Next Generation Sequencing.
+ Experience in CDx and/or precision medicine.
+ Design for Six Sigma and/or other process methodology tools training.
+ Certification as a Clinical Research Professional.
**Physical Demands**
+ Employee may be required to lift routine office supplies and use standard office equipment.
+ Ability to sit for extended periods of time.
+ Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.
**Training**
+ All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
**Other**
+ This position requires periodic travel and some evenings, weekends and/or holidays.
+ 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.
Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.
Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.