Source Document Specialist

How This Role Makes a Difference

Care Access Research is currently looking to hire a full time, remote, Source Document Specialist. The Source Document Specialist will be responsible for creating, maintaining, and controlling accurate versions of source documents (eSource or paper) for each clinical trial to substantiate trial activities.

How You'll Make An Impact

• All source documents will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to Care Access Research internal SOP.
• Initial creation of e-Source with use of all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided templates/worksheets, or reference manuals) to design source documents that are accurate and complete and to ensure that the source document is equipped to record all the required data for a clinical trial.
• Create paper source templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Review draft source and ensure it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinate initial source review and update process.
• Maintain version control of all source documents.
• Update current source as needed per protocol amendments.
• File, maintain, distribute, organize, and archive source for each clinical trial.
• Manage daily communication with Site staff and other internal departments

The Expertise Required

• Experience as a Clinical Research Coordinator with diverse and complex clinical trials preferred.
• Skilled and proficient with e-Source build and design (e.g. CRIO/Clinical Conductor)
• Skilled in creation and revision of paper source templates.