Clinical QC Reviewer - Compliance & Audit

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