Care Access

Care Access

Source Document Specialist

USA Remote · Full-time

No sponsorship$30k-$35kDetected 6 days ago
GCPComplianceExcelClinical TrialsClinical ResearchPublic HealthResearchCommunicationProblem SolvingOrganizational SkillsMicrosoft OfficeSharePointGxP

About the role

  • About Care Access Care Access is working to make the future of health better for all.
  • With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care.
  • To learn more about Care Access, visit www.CareAccess.com.

Responsibilities

  • Review and validate source documents (eSource and paper) to ensure completeness, accuracy, and alignment with study protocols, while ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.
  • Manage daily communication with site staff, study teams, and internal departments regarding source document updates, requests, and training support.
  • Support quarterly initiatives, including process improvements, training development, and workflow optimizations for source documentation
  • Provide feedback to help update standardized templates and checklists to improve the efficiency of source document review.
  • Strong attention to detail is essential to identify discrepancies, manage version control, and ensure accuracy and traceability of source documentation.

Requirements

  • Review protocol amendments and other study changes to assess impact on source documents, communicate required updates to the source team, and submit revisions as needed.
  • The Expertise Required
  • Fluency in English (reading, writing, and speaking) is required to communicate effectively with the global Source team and to review English‑language protocols, manuals, and regulatory documentation.
  • The role requires proficiency in Microsoft Excel, Word, Outlook, Teams, and SharePoint, along with the ability and willingness to work within eSource platforms such as CRIO.

Nice to have

  • Minimum of 2 years of experience in clinical research, with preferred experience as a Clinical Research Coordinator (CRC) or in a role involving source documentation, study execution, or regulatory compliance.
  • Strong knowledge of clinical trial operations, including protocol interpretation, source creation, and site workflow processes.
  • Experience working with Good Clinical Practice (GCP) guidelines, 21 CFR Part 11 compliance, and clinical trial documentation standards.
  • Microsoft Excel, Word, SharePoint, and other digital documentation tools.
  • Certified Clinical Research Coordinator (CCRC) - from ACRP (Association of Clinical Research Professionals)
  • Certified Clinical Research Professional (CCRP) - from SOCRA (Society of Clinical Research Associates)
  • Good Clinical Practice (GCP) Certification. required or obtained upon hire.
  • The Source Document Specialist must demonstrate a strong understanding of clinical trial protocols, GCP, and applicable regulatory requirements, including 21 CFR Part 11, to ensure compliant source documentation.

Compensation

  • The expected pay range for this role is $30.00 - $35.00 USD per hour for full time team members.

Benefits

  • Bachelor's degree in a health-related field (e.g., Life Sciences, Nursing, Public Health, or a related discipline) preferred.
  • Paid Time Off (PTO) and Company Paid Holidays
  • Certifications/Licenses, Education, and Experience
  • Minimum Education:
  • Benefits & Perks (US Full Time Employees)

Company info

  • The position requires comfort working both independently and as part of a global team, managing multiple systems, and adapting to evolving research and technology needs.

Visa & Work Authorization

  • Care Access is unable to sponsor work visas at this time
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This listing is sourced directly from Care Access's careers page and normalized into a canonical job model.