Source Documentation Assistant

We are actively hiring a

Source Documentation Assistant

to support our Valkyrie Clinical Trials Century City, Los Angeles, CA site.

The Source Documentation Assistant plays a vital role in the day-to-day operational integrity of our oncology clinical research site. This individual is responsible for the accurate organization, uploading, and filing of source documents within our electronic document management system—ensuring that every active study maintains complete, compliant, and accessible trial records in accordance with regulatory standards and internal SOPs.

Location
Onsite, Century City, Los Angeles, CA

FLSA
Non-Exempt

Hours
Monday to Friday, Day Shift, 40 hours per week

Compensation
$23.00 – $27.00 per hour (depending on experience)

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

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

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, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

EEO Statement
Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.

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