Onsite Source Documentation Specialist - Oncology Trials

Flourishresearch; California (MO); On-site; USD 31,684 - 37,195; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with 100% employer match on the

4% contributed employee match

Job summary

Flourish Research's Valkyrie Clinical Trials Century City, Los Angeles, CA site is seeking a Source Documentation Assistant to support day-to-day operations. You will organize, upload, and file source documents in our electronic document management system to keep study records complete, compliant, and inspection-ready.

This onsite role requires a high school diploma (associate’s or bachelor’s preferred) and at least one year in clinical research or document management.

Qualifications

• High school diploma or equivalent; associate’s/bachelor’s preferred.
• Minimum of one year in clinical research, document management, or an administrative role.
• Familiarity with clinical trial documentation and regulatory binders.
• Working knowledge of ICH GCP and FDA regulatory requirements.
• Experience with electronic document management and signature platforms.

Responsibilities

• Collect, review, and organize source documents from clinical sites and study teams.
• Upload source documents into the electronic document management system accurately and timely.
• Index and file documents per naming conventions and SOPs.
• Perform quality checks to verify completeness and correct classification.
• Track receipt and filing status; escalate missing records as needed.
• Maintain logs and tracking tools to support audit-readiness.
• Coordinate with operations, data management, and regulatory teams to resolve discrepancies.
• Assist with archival of study records at closeout per regulations.
• Support audits by retrieving and presenting documentation.
• Adhere to 21 CFR Part 11, ICH E6(R2) GCP, and privacy regulations.

Skills

Source documentation management

Attention to detail

Regulatory compliance

Medical terminology

Document control

Communication skills

Team collaboration

Education

High school diploma or equivalent

Associate’s or bachelor’s degree preferred

Tools

Veeva Vault

Trial Interactive

RealTime CTMS

SignNow

Job description

Flourish Research's Valkyrie Clinical Trials Century City, Los Angeles, CA site is seeking a Source Documentation Assistant to support day-to-day operations. You will organize, upload, and file source documents in our electronic document management system to keep study records complete, compliant, and inspection-ready.

This onsite role requires a high school diploma (associate’s or bachelor’s preferred) and at least one year in clinical research or document management.