Clinical Trial Specialist

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

A Clinical Trial Specialist provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principals. Responsibilities will include, but not limited to, study documentation maintenance, IRB submissions, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, accessioning, and inventory.

Job Responsibilities

• Successfully execute site onboarding process in an effective and timely manner

• Develop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support.

• Monitor and facilitate local site IRB and central IRB activities, including additional site submissions, amendments/changes in research submissions, create/facilitate submission of annual continuing review reports, monitor and notify of document expiration dates, and process fees through accounts payable.

• Oversees creation of new study and site Trial Master File (TMF) entries, including site information and required documents.

• Ensures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol.

• Maintains operational study documents; SOPs, Working Instructions, Lab Manuals, User Guides, and study specific forms that include tracking, preventative maintenance, instrument logs, quality assessments, reports and audits.

• Communicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group.

• Responsible for ensuring sample integrity and maintaining Good Clinical Practice (GCP) compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions. This includes, but not limited to, collecting requisite information, performing data entry for sample tracking/reporting, sample inventory, sample distribution and communicating status with key stakeholders (internal/external).

• Oversees the shipment tracking, receipt, storage/inventory, maintenance and transfer/distribution of non-clinical samples and clinical study biospecimens.

• Maintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under direction of manager.

• Reviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment.

• Enters specimen information into Sample Management System.

• Reviews associated specimen submission documentation and verified accuracy of data entry.

• Coordinates and assists in deidentification of specimen requests for purposes of research.

Required Qualifications

• Associate or higher degree with biological science coursework required.

• Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook.

• Candidates should have 1-2 years’ experience in a Biorepository setting or Clinical Trial setting.

• Experience in handling human biological materials

• Demonstrates the ability to effectively and respectfully communicate with coworkers, staff, sponsors, and cl