Source Document Specialist

Job Description

REQUIREMENTS

• 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.
• Ability to interpret clinical trial protocol and determine how to design complete and accurate source documents.
• Self-motivated, task oriented, detailed person who can work independently prioritizing responsibilities and adhering to project deadlines.
• Ability to create source documents in Excel.
• Willing to learn computerized programs used in creating eSource.
• Good verbal and written communication skills, especially for the remote work environment, including editing, proofreading, and grammar skills.
• Highly organized.
• IT Skills including Word, Email and Direct Messaging, digital document maintenance, and expert level in Excel.
• Ability to work well within a team.

Certifications/Licenses, Education, and Experience

• • Minimum Education:
    • Bachelor’s degree in a relevant field (Life Sciences, Healthcare, or related discipline), or relevant experience.

RESPONSIBILITIES

• 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

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