Clinical Trial Specialist - Biorepository

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-Biorepository 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 principles. Responsibilities will include, but not limited to, study documentation maintenance, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, 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.

• Liaison with study sites and regulatory document team to ensure regulatory documentation is up to date.

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

• 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.

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

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

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

• Continuously provides excellent customer service in an efficient and effective manner.

Required Qualifications

• Associate degree with biological science coursework required.

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

• Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, Outlook, and general working knowledge of Internet for business use

Preferred Qualifications

• BS degree or higher degree with biological science

• 3-5 years’ experience

• Candidates should have experience with clinical trial regulatory documentation or TMF.

• Candidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment.

• Laboratory Information Management System or Sample Management System experience.

• Customer service experience.

• Good Clinical Practice training, IATA training, and Human Subject Protection training.

Physical Demands

• Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time.

• Ability to lift up to 30 lbs.

Training

• Employee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training.

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• Weekend/evening/holiday work may be required depending on business need, however, is not to be the norm.

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.