Clinical Trial Documentation Coordinator

Caris Life Sciences; United States; Remote; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Paid time off

401k match

Employee Assistance Program

Pet Insurance

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored studies and collaborative pharmaceutical research. You will ensure study documents are current, complete, and compliant, coordinating IRB submissions and maintaining trial documentation.

You will liaise with internal teams, sites, IRBs, and sponsors to facilitate timely regulatory submissions, track progress in CTMS, and support site onboarding throughout the trial lifecycle.

Qualifications

• Associates degree with 2 years’ experience submitting documents to IRBs.
• Strong understanding of clinical research documentation and regulatory processes.
• Proficient in Microsoft Office Suite and navigating regulatory/trial management systems.
• Excellent organizational and communication skills with attention to detail.
• Ability to manage multiple studies with minimal supervision.

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.
• 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 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 documentation timelines.
• Support compliance with federal, state, and local regulations, including GCP, HIPAA, FDA, OHRP, and related 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 SOP development as needed.

Skills

Regulatory knowledge

Documentation management

Multitasking

Attention to detail

Communication

Education

Associate degree

Bachelor’s degree in life sciences or healthcare

Tools

Microsoft Office

CTMS

Job description

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored studies and collaborative pharmaceutical research. You will ensure study documents are current, complete, and compliant, coordinating IRB submissions and maintaining trial documentation.

You will liaise with internal teams, sites, IRBs, and sponsors to facilitate timely regulatory submissions, track progress in CTMS, and support site onboarding throughout the trial lifecycle.