Caris Life Sciences·Phoenix, Arizona
The specialist provides clinical study support by maintaining study documentation and coordinating IRB submissions for pharmaceutical research. They serve as a liaison between internal teams, research sites, and sponsors to ensure regulatory compliance and timely approvals.
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.
The Clinical Study Documentation Specialist provides clinical study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The activities in this role will be conducted in alignment with internal standard operating procedures (SOPs), regulatory requirements, and industry best practices. Responsibilities include maintaining study documentation, coordinating Institutional Review Board (IRB) submissions, engaging with research sites through regular meetings, and regular assessments of clinical study documents to confirm they are current, complete, and compliant.
Job Responsibilities
Support initiation and maintenance of clinical trials by preparing and submitting study documents including protocols, informed consent forms, investigator brochures, and amendments to IRBs and other oversight entities.
Maintain accurate and up-to-date clinical study files and documentation, including licenses, staff certifications, training records, and equipment logs, ensuring all required elements are readily available for inspection or audit.
Coordinate and conduct regular reviews of study binders and systems to ensure documents are non-expired, complete, and aligned with protocol requirements.
Serve as a liaison between internal teams, research sites, IRBs, and sponsors to facilitate clear communication, resolve issues, and ensure timely regulatory submissions and approvals.
Track study progress in applicable databases and platforms, updating milestones and document statuses in clinical trial management systems (CTMS), IRB portals, spreadsheets, and sponsor systems as required.
Assist with site onboarding and study activation, providing study guidance and support throughout the trial lifecycle.
Participate in internal and external meetings, including site calls and sponsor touchpoints, to provide updates on study status and clinical study documentation timelines.
Support compliance with federal, state, and local regulations, as well as GCP, HIPAA, FDA, OHRP, and other applicable guidelines.
Assist with the development and delivery of GCP training for internal stakeholders and research staff.
Maintain awareness of changes in clinical regulatory processes and assist in the development of new processes or SOPs as needed.
Required Qualifications
Associates degree
2 years experience with preparing and submitting documents to Institutional Review Boards (IRBs).
Strong understanding of clinical research documentation, clinical regulatory processes, and protocol development.
Proficient in Microsoft Office Suite (Word, Excel, Outlook) and capable of navigating internet-based systems for regulatory and trial management.
Strong organizational skills and attention to detail in documentation and communication.
Ability to manage multiple studies and competing priorities with minimal supervision.
Successful completion of pre-employment requirements including criminal background check, drug screening, and reference check.
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.
Requires an associate degree and at least 2 years of experience preparing and submitting documents to Institutional Review Boards. Proficiency in Microsoft Office and a strong understanding of clinical regulatory processes are essential.
Market context
In Arizona, physician openings are often shaped by ongoing demand in hospitals, clinics, and specialty care settings, especially where patient volume and care coordination are high. These roles are competitive because employers typically look for strong clinical experience, state licensure, and specialty background; in this posting, the requirements are AI-summarized from the original job description, helping you review fit faster. If you are considering applying, confirm your Arizona license status and align your experience with the listed respiratory care and vascular access background before submitting.
