Impactful Clinical Trial Documentation Specialist

Caris Life Sciences; Phoenix (AZ); On-site; USD 65,000 - 90,000; Full time

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored studies and collaborative research initiatives. You will prepare and submit regulatory documents, maintain study files, and coordinate IRB submissions to ensure compliance with GCP, HIPAA, and FDA guidelines.

The role involves liaising with internal teams, research sites, IRBs, and sponsors, tracking trial progress in CTMS, and supporting site onboarding throughout the trial lifecycle in a

Qualifications

• Associates degree required.
• 2 years IRB submission experience.
• Proficient with MS Office and CTMS familiarity.
• Strong organizational skills and attention to detail.

Responsibilities

• Prepare and submit study documents to IRBs.
• Maintain clinical study files and training records.
• Coordinate reviews of study binders and systems.
• Track study progress in CTMS and sponsor systems.
• Assist with site onboarding and study activation.
• Support regulatory submissions and approvals.

Skills

Organizational skills

Attention to detail

Regulatory knowledge

Communication

Education

Associate degree

Bachelor's degree in life sciences/healthcare

Tools

Microsoft Office Suite

CTMS

Job description

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored studies and collaborative research initiatives. You will prepare and submit regulatory documents, maintain study files, and coordinate IRB submissions to ensure compliance with GCP, HIPAA, and FDA guidelines.

The role involves liaising with internal teams, research sites, IRBs, and sponsors, tracking trial progress in CTMS, and supporting site onboarding throughout the trial lifecycle in a