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Flourish Research

Clinical trial optimization and operations efficiency

Source Documentation Assistant - Valkyrie

Clinical Support & Patient AdministrationConfirmed live in the last 24 hours
Full-timeLos Angeles, CA, USA$23 - $27 /hr

About the Job

Requirements

  • A high school diploma or equivalent is required.
  • At least one year of experience in clinical research, document management, or an administrative role is required.
  • Familiarity with clinical trial documentation, including informed consent forms, case report forms, and regulatory binders.
  • Working knowledge of ICH Good Clinical Practice 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.
  • Ability to manage high volumes of documentation, prioritize competing responsibilities, and meet deadlines.
  • Ability to take ownership of documentation responsibilities and identify and resolve document gaps through critical thinking and proactive problem-solving.
  • Ability to adjust priorities to 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 accurately and in a timely manner into the electronic document management system.
  • Index and file documents according to established naming conventions, filing structures, and standard operating procedures.
  • 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 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 archiving study records at study closeout in accordance with applicable regulations.
  • Support internal and external audits by retrieving and presenting documentation as requested.
  • Follow 21 CFR Part 11, ICH E6(R2) Good Clinical Practice guidelines, and applicable data privacy regulations in documentation activities.

Desired Qualifications

  • An associate’s or bachelor’s degree is preferred.
  • Experience within a contract research organization, pharmaceutical company, or clinical research site is preferred.

About the Company

Flourish Research

Clinical trial optimization and operations efficiency

Flourish Research helps healthcare and pharmaceutical clients run clinical trials more efficiently. It offers tailored optimization services that improve trial operations, aiming to reduce time and costs to bring new treatments to market. The company leverages decades of experience to provide quality-driven solutions, focusing on expanding capabilities, developing healthy teams, and implementing processes that enhance speed and quality across trial activities. Flourish Research differentiates itself by its client-specific approaches and strong emphasis on quality, team development, and operational excellence to deliver reliable trial outcomes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Apex, NC
Founded
2021

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