Clinical QC Reviewer - Compliance & Audit

Description

Review and modify submission-ready clinical documents by demonstrating high attention to detail, in order to guarantee quality of the final document. Responsibilities cover the following 3 specific areas of Document Quality Review: clinical data checking/consistency checking, clinical editing, and Special assignments/writing projects.

Responsibilities:

• Independently performs Document Quality Review of assigned clinical, regulatory or publication documents for the Clinical Research organization.
• Formally documents Document Quality Review findings of assigned documents.
• Alerts supervisor and document authors immediately if significant problems are found during a Document Quality Review.
• After completion of Document Quality Review, prepares written report of findings in a table of observations.
• Participates in resolution of table of observations with the document authors and if necessary, unit head/manager.
• Keeps management and authors informed on progress of document quality reviews.
• Archives relevant Document Quality Review documentation of the completed Document Quality Review in accordance with departmental requirements.
• May initiate the preparation of project style guides and coordinate agreement on style issues across projects.
• Review Docs against source and perform Cross-tracking

Clinical Document Compliance duties:

• Staying current with applicable regulatory and SOP requirements.
• Completing assigned training on time.
• Shares information and experiences with team members, both formally (eg, team meetings) and informally.

Administrative Tasks:

• Records assignments in relevant tasks logs.
• Provides monthly and quarterly reports with type and number of documents completed in a workload tracking database and uses queries to sort for quarterly statistics

SKILLS:

Clinical Documentation, Regulatory Documentation experience required

• Attention to detail and good oral/written communication skills required
• 3+ year clinical trials knowledge required
• Medical Writing experience required
• Must have at least a Bachelor's Degree.
• The ability to work independently to think through results, resolve data discrepancies, be able to comb through long data dense documents, analyze, interpret and apply new clinical data with a focus on the key messages is essential.
• Ability to review data across multiple documents for consistency.
• Must be able to actively participate in cross-functional clinical teams and provide deliverables according to timelines.
• Must have a background in QC/QA and Documentation