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Source Document Specialist

12 hours, 56 minutes ago
United States
Full-time
Junior
Technical Writer
Technical Writing and Documentation
Apply Now
Care Access

Care Access

Care Access is a decentralized research organization (DRO) that accelerates the future of medicine by breaking down traditional barriers in clinical research and expanding the impact of research to previously unreachable patient populations.

Diversified Consumer Services
251-1K
View All Jobs 4

Description

  • Create eSource documents using protocol-specific materials such as IRB-approved protocols, CRFs, sponsor templates, worksheets, and reference manuals.
  • Create paper source templates, worksheets, and supplemental source documents based on protocol-defined exams, tests, evaluations, and assessments.
  • Review draft source documents to ensure they are accurate, complete, and able to capture all required trial data.
  • Coordinate the initial source review and update process.
  • Maintain version control of all source documents.
  • Update source documents as needed to reflect protocol amendments.
  • File, maintain, distribute, organize, and archive source documents for each clinical trial.
  • Communicate daily with site staff and internal departments.
  • Ensure all source documents follow GCP guidelines, 21 CFR Part 11 compliance, and internal SOPs.

Requirements

  • Bachelor's degree in a relevant field such as Life Sciences, Healthcare, or a related discipline, or equivalent relevant experience.
  • Experience as a Clinical Research Coordinator with diverse and complex clinical trials preferred.
  • Skilled and proficient in e-Source build and design, such as CRIO or Clinical Conductor.
  • Skilled in creating and revising paper source templates.
  • Ability to interpret clinical trial protocols and design complete, accurate source documents.
  • Ability to create source documents in Excel, with expert-level Excel proficiency.
  • Strong verbal and written communication skills for a remote work environment, including editing, proofreading, and grammar.
  • Highly organized, self-motivated, and detail-oriented, with the ability to work independently and meet deadlines.
  • Ability to work well within a team.
  • Willingness to learn computerized programs used to create eSource.

Benefits

  • Expected pay range of $30.00 to $35.00 USD per hour for full-time team members.
  • Paid Time Off and company-paid holidays.
  • 100% employer-paid medical, dental, and vision insurance plan options.
  • Health Savings Account and Flexible Spending Accounts.
  • Bi-weekly HSA employer contribution.
  • Company-paid Short-Term Disability and Long-Term Disability.
  • 401(k) retirement plan with company match.

Interested in this position?

Apply directly on the company website

Apply Now

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