Remote Source Documentation Specialist

Paycom

Austin (TX)

On-site

USD 65,000 - 95,000

Full time

11 days ago
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Job summary

Paycom seeks a Source Creation Specialist to ensure accuracy and regulatory compliance of study source documents across trials. You will design, develop, and maintain study-specific sources, supporting quality control and inspection readiness in a fully remote role.

Responsibilities include reviewing protocols, tailoring compliant sources, staff training, audits support, and collaboration with CTMS and finance to ensure data integrity and timely updates across markets.

Qualifications

  • Bachelor’s degree in life sciences, healthcare, or related field.
  • 2–4 years of experience in clinical research, including source document creation.
  • Strong knowledge of GCP, FDA, and ICH requirements.
  • Excellent attention to detail and document management skills.
  • Complex specialty therapeutic area trial experience preferred (e.g., Urology, Neurology, Endocrinology).
  • Ability to collaborate across multiple teams and stakeholders.
  • Understanding of clinical trial budgets and how they relate to source documentation creation in a CTMS system.
  • Exceptional time management skills and the ability to prioritize varying trial recruitment timelines.
  • Excellent communication skills and the ability to interact with all levels of management, staff, vendors, sponsors, and providers.

Responsibilities

  • Review study protocols and creates compliant source documents tailored to each protocol for all research trials in each company market.
  • Collaborate with study teams, investigators, and coordinators to ensure usability of source forms.
  • Ensure that all source documents meet sponsor, IRB, and regulatory requirements.
  • Update and revise source templates based on protocol amendments or feedback.
  • Maintain version control and archiving of all source documents.
  • Train site staff on correct use of source documents to ensure accurate data capture.
  • Support audits and inspections by providing well-documented, compliant source materials.
  • Collaborate with finance to ensure all invoiceable are correctly tied to source within the CTMS system.
  • Participate in study kick off calls to communicate source development efforts and train site staff on source specifics.
  • Collaborate with site staff and site managers to ensure protocol updates and all up to date eCRF guidelines are available for use in a timely manner.
  • Proactively roll out source post protocol amendment and ensure site staff is aware of source updates.
  • Work alongside finance to review and/or create budget templates within the CTMS system to support source creation.
  • Follows up with staff to resolve internal data queries within the CTMS as needed.
  • Updates source documents as updates to protocols occur and errors are found.
  • Support with analyzing quality data to determine areas of growth and improvement.
  • Supports strategy to improve quality across all markets.
  • Facilitates ongoing trainings and shadows visits as needed for eSource use and quality improvement.
  • Other duties as assigned

Skills

Attention to detail
Documentation
Communication
Time management
Team collaboration
Deductive reasoning

Education

Bachelor’s degree in life sciences or related field

Tools

CTMS
Clinical research software

Job description

Paycom seeks a Source Creation Specialist to ensure accuracy and regulatory compliance of study source documents across trials. You will design, develop, and maintain study-specific sources, supporting quality control and inspection readiness in a fully remote role.

Responsibilities include reviewing protocols, tailoring compliant sources, staff training, audits support, and collaboration with CTMS and finance to ensure data integrity and timely updates across markets.

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