Clinical Trial Documentation & Compliance Specialist

Caris Life Sciences; Phoenix (AZ); On-site; USD 60,000 - 80,000; Full time

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored and collaborative research. The role focuses on maintaining compliant study documentation, coordinating IRB submissions, and liaising with research sites, IRBs, and sponsors to ensure timely regulatory actions.

You will ensure documents are current, complete, and compliant, manage study files and training records, and assist with CTMS updates and regulatory guidance across the trial lifecycle.

Qualifications

• Associates degree required; 2 yrs IRB document submission experience preferred.
• Strong understanding of regulatory processes and clinical trial documentation.
• Experience with protocol development and study files management.
• Proficiency with MS Office and electronic regulatory systems.

Responsibilities

• Prepare and submit study documents (protocols, consent forms, investigator brochures) to IRBs and regulators.
• Maintain accurate study files including licenses, training, and equipment logs.
• Coordinate regular reviews of study binders to ensure documents are current and compliant.
• Serve as liaison among internal teams, sites, IRBs, and sponsors for timely submissions and approvals.
• Track study progress in CTMS, IRB portals, and sponsor systems; update milestones.

Skills

Regulatory knowledge

Clinical research documentation

Protocol development

Microsoft Office

Organizational skills

Communication

Education

Associates degree

Bachelor's degree in life sciences/healthcare/related

Tools

CTMS

Microsoft Office Suite

Job description

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored and collaborative research. The role focuses on maintaining compliant study documentation, coordinating IRB submissions, and liaising with research sites, IRBs, and sponsors to ensure timely regulatory actions.

You will ensure documents are current, complete, and compliant, manage study files and training records, and assist with CTMS updates and regulatory guidance across the trial lifecycle.