Clinical Trial Documentation Pro

Caris MPI, Inc.; Phoenix (AZ); On-site; USD 60,000 - 90,000; Full time

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist in Phoenix to support Caris-sponsored trials and regulatory submissions. You will maintain study files, prepare documents like protocols, consent forms, investigator brochures, and amendments to IRBs, ensuring accuracy and audit readiness.

The role requires an Associate degree, strong regulatory knowledge, proficiency in Microsoft Office and CTMS, and the ability to manage multiple studies with minimal supervision.

Qualifications

• Must have solid understanding of clinical research documentation and regulatory processes.
• Experience preparing and submitting documents to IRBs and other oversight bodies.
• Strong organizational skills and attention to detail in documentation and communication.

Responsibilities

• Prepare and submit study documents (protocols, informed consent forms, investigator brochures, amendments) to IRBs and sponsors.
• Maintain accurate study files, licenses, staff certifications, and training records.
• Regularly review study binders to ensure documents are current and compliant.
• Track study progress in CTMS, IRB portals, and sponsor systems; update milestones and statuses.
• Assist with site onboarding and study activation; support trial lifecycle.

Skills

IRB submissions

Regulatory compliance

Documentation excellence

Multitasking

Education

Associate degree in life sciences or related field

Bachelor's degree in life sciences, healthcare, or related field

Tools

Microsoft Office Suite

CTMS

Job description

Caris Life Sciences is seeking a Clinical Study Documentation Specialist in Phoenix to support Caris-sponsored trials and regulatory submissions. You will maintain study files, prepare documents like protocols, consent forms, investigator brochures, and amendments to IRBs, ensuring accuracy and audit readiness.

The role requires an Associate degree, strong regulatory knowledge, proficiency in Microsoft Office and CTMS, and the ability to manage multiple studies with minimal supervision.