Clinical Study Documentation Specialist - eTMF Specialist

Caris MPI, Inc.; Irving (TX); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Health Savings Account

Flexible Spending Account

Paid time off

401k match

LTD and STD insurance

Employee Assistance Program

Pet Insurance

Legal Assistance

Tuition Assistance

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to provide study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The role aligns with SOPs, regulatory requirements, and industry best practices.

You will maintain study documentation, coordinate IRB submissions, engage with research sites, and ensure documents are current, complete, and compliant throughout the trial lifecycle.

Qualifications

• Associates degree with 2 years experience preparing and submitting documents to IRBs.
• Strong understanding of clinical research documentation and regulatory processes.
• Proficient in Microsoft Office and capable of navigating internet-based regulatory/trial systems.
• 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 background check, drug screening, and reference check.

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 inspection readiness.
• Coordinate and conduct regular reviews of study binders and systems to ensure documents are non-expired and aligned with protocol requirements.
• Serve as a liaison between internal teams, sites, IRBs, and sponsors to facilitate communication and timely regulatory submissions.
• Track study progress in CTMS, IRB portals, spreadsheets, and sponsor systems; update milestones and document statuses.
• Assist with site onboarding and study activation, providing guidance and support throughout the trial lifecycle.
• Participate in meetings to provide updates on study status and documentation timelines.
• Support compliance with regulatory guidelines (GCP, HIPAA, FDA, OHRP) and changes in processes.
• Assist with development and delivery of GCP training for internal stakeholders and staff.

Skills

Clinical research documentation

IRB submissions

Regulatory compliance

Documentation management

Communication

Education

Associate's degree

Bachelor's degree (preferred)

Tools

Microsoft Office

Job description

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 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

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.

Preferred Qualifications

• Working knowledge of ICH-GCP, FDA, DHHS, and OHRP regulations and guidelines.
• Bachelor's degree in life sciences, healthcare, or a related field.
• At least two years of experience in a clinical research or regulatory environment.
• Experience working with electronic clinical trial management systems (CTMS).
• Certifications such as CCRC, CCRP, or RAC are a plus.

Physical Demands

• Ability to sit or stand for prolonged periods (more than 1 hour at a time).
• Ability to lift up to 30 lbs as needed.

Training

• Completion of Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training.
• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other Availability

Availability to respond to after‑hours issues in rare cases where urgent regulatory support is required.

Annual Hiring Range

$65,000 - $85,000

Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level.

The pay ratio between base pay and target incentive (if applicable) will be finalized at offer.

Description of Benefits

• Highly competitive and inclusive medical, dental and vision coverage options
• Health Savings Account for medical expenses and dependent care expenses
• Flexible Spending Account to pay for certain out‑of‑pocket expenses
• Paid time off, including: vacation, sick time and holidays
• 401k match and Financial Planning tools
• LTD and STD insurance coverages, as well as voluntary benefit options
• Employee Assistance Program
• Pet Insurance
• Legal Assistance
• Tuition Assistance

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.

Equal Opportunity

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.