Onsite Source Documentation Specialist – Clinical Trials

Flourish Research; Milnerton; On-site; ZAR 533,055 - 625,760; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Tuition reimbursement

Parental leave

Employee referral program

Employee assistance program

Life insurance

Disability insurance

Paid time off

Job summary

Flourish Research is hiring a Source Documentation Assistant for our Valkyrie Clinical Trials Century City site in Los Angeles, CA. The role focuses on organizing, uploading, and filing source documents in our electronic document management system, ensuring complete, compliant, and accessible trial records.

Responsibilities include indexing, quality checks, coordinating with operations, data management, and regulatory teams to resolve discrepancies, and supporting audits while adhering to ICH

Qualifications

• Minimum of one year of experience in clinical research, document management, or an administrative role.
• Experience with electronic document management and signature platforms such as Veeva Vault, Trial Interactive, RealTime CTMS, SignNow.
• Familiarity with ICH GCP guidelines and FDA regulatory requirements.
• Familiarity with Trial Master File structure, document filing standards, and audit-readiness best practices.
• Working knowledge of clinical trial documentation including informed consent forms, case report forms, and regulatory binders.

Responsibilities

• Collect, review, and organize source documents from clinical sites.
• Upload source documents into the electronic document management system.
• Index and file documents according to naming conventions and SOPs.
• Perform quality checks on uploaded documents for completeness and legibility.
• Track document receipt and filing status, escalating gaps.
• Maintain document 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 study closeout.
• Support audits by retrieving and presenting documentation.
• Adhere to 21 CFR Part 11, ICH E6(R2) GCP, and privacy regulations.
• Other duties as assigned.

Skills

Organizational skills

Attention to detail

Communication skills

Problem solving

Time management

Teamwork

Flexibility

Proactivity

Multidisciplinary collaboration

Education

High school diploma

Associate or bachelor's degree preferred

Tools

Veeva Vault

Trial Interactive

RealTime CTMS

SignNow

Job description

Flourish Research is hiring a Source Documentation Assistant for our Valkyrie Clinical Trials Century City site in Los Angeles, CA. The role focuses on organizing, uploading, and filing source documents in our electronic document management system, ensuring complete, compliant, and accessible trial records.

Responsibilities include indexing, quality checks, coordinating with operations, data management, and regulatory teams to resolve discrepancies, and supporting audits while adhering to ICH