Source Documentation Assistant

Flourish Research • Los Angeles, CA

10d • $23 - $27 • Onsite

About The Position

Flourish Research is a progressive clinical trial organization with expertise in various research areas. Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network. VCT is actively hiring a Source Documentation Assistant to support its Century City, Los Angeles, CA site. The Source Documentation Assistant is crucial for the daily operational integrity of the oncology clinical research site. This role involves the accurate organization, uploading, and filing of source documents within an electronic document management system, ensuring all active studies maintain complete, compliant, and accessible trial records according to regulatory standards and internal SOPs.

Requirements

• High school diploma or equivalent required; associate’s or bachelor’s degree preferred
• Minimum of one year of experience in clinical research, document management, or an administrative role
• Experience within a CRO, pharmaceutical company, or clinical research site preferred
• Familiarity with clinical trial documentation, including informed consent forms, case report forms, and regulatory binders
• Working knowledge of ICH GCP guidelines and FDA regulatory requirements
• Familiarity with Trial Master File structure, document filing standards, and audit-readiness best practices
• Experience with electronic document management and signature platforms, such as Veeva Vault, Trial Interactive, RealTime CTMS, SignNow, or similar systems
• Proficiency with computers and Microsoft Office Suite, including Word, Excel, and Outlook
• Working knowledge of basic medical terminology
• Impeccable organizational skills and attention to detail
• Ability to manage high volumes of documentation, prioritize competing responsibilities, and meet deadlines
• Excellent written and verbal communication skills
• A reliable and accountable mindset, with ownership of documentation responsibilities
• High-level critical thinking and proactive problem-solving skills to identify and resolve document gaps
• A collaborative and professional approach to working with multidisciplinary clinical research teams
• Flexibility to adjust priorities and ensure studies remain compliant, on schedule, and audit-ready

Responsibilities

• Collect, review, and organize source documents received from clinical sites and study teams.
• Upload source documents into the electronic document management system accurately and in a timely manner.
• Index and file documents according to established naming conventions, filing structures, and SOPs.
• Perform quality checks on uploaded documents to verify completeness, legibility, and correct classification.
• Track document receipt and filing status, escalating missing or incomplete records to the appropriate team members.
• Maintain document logs and tracking tools to support audit-readiness and inspection preparedness.
• Coordinate with clinical operations, data management, and regulatory teams to resolve document-related discrepancies.
• Assist with the archival of study records at study closeout in accordance with applicable regulations.
• Support internal and external audits by retrieving and presenting documentation as requested.
• Adhere to 21 CFR Part 11, ICH E6(R2) GCP guidelines, and applicable data privacy regulations in all documentation activities.
• Other duties as assigned or required.

Benefits

• Health, dental, and vision insurance plans
• 401(k) with a 100% employer match on the first 4% of employee contributions
• Tuition reimbursement
• Parental leave
• Employee referral program
• Employee assistance program
• Life insurance
• Disability insurance
• Generous PTO plan covering vacation, sick, personal days and 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED