Source Documentation Assistant

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 is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panorama City, and Murrieta, and has recently expanded to Denver, Colorado.

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.

• 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 preferredFamiliarity 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

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.

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.