JOB DESCRIPTION:

The Clinical Documentation Specialist is responsible for performing key operational activities across the Clinical Documentation Center (CDC) for trial master files throughout their lifecycle. This role collaborates with Master File Owners and cross-functional stakeholders to ensure inspection readiness, compliance with GCP, and data integrity of clinical documentation.

Responsibilities:

• Apply critical thinking to ensure real-time inspection readiness of clinical documentation by investigating and resolving issues, running reports and dashboards within eTMF, producing metrics, and communicating root cause analyses to Master File Owners.
• Lead final reconciliation, review, and archival of individual master files, working closely with Clinical Documentation Associates (CDAs), CDC leadership, and other stakeholders (e.g., CPD, SM&M, DSS, BSO).
• Support CRO-managed study TMFs, including quality checks of artifacts, uploading/classifying, and coordinating transfers of CRO TMFs into client’s eTMF system.
• Provide audit and inspection preparation support for paper and electronic TMFs: conduct data integrity checks, analyze TMF completeness, follow up on outstanding items, and complete pre-inspection requests.
• Act as subject matter expert during inspections, supporting eTMF system navigation, responding to auditor/inspector requests, and providing documentation as needed.
• Participate in TMF conversion and transfer activities from CROs or other external entities.
• Review regulatory document packages for Investigational Product (IP) release, work with Artifact Owners to resolve discrepancies, and provide approval for release to investigator sites.
• Contribute to continuous improvement by suggesting enhancements for work instructions, job aids, and participating in functional area initiatives.
• Ensure full compliance with GCP, client SOPs, and established processes.

Requirements:

• Bachelor’s degree (or international equivalent) preferred. Minimum 4 years of relevant clinical documentation/clinical research experience, or 6 years without a degree.
• Strong knowledge of clinical documentation processes, TMF/eTMF systems, and regulatory compliance standards (GCP, SOPs).
• Proven analytical and critical thinking skills with ability to identify issues, conduct root cause analysis, and implement solutions.
• Ability to work independently with minimal oversight while managing multiple priorities.
• Excellent oral and written communication skills, with the ability to collaborate effectively across functions and represent CDC during audits/inspections.

• Apply critical thinking to ensure real-time inspection readiness of clinical documentation by investigating and resolving issues, running reports and dashboards within eTMF, producing metrics, and communicating root cause analyses to Master File Owners.
• Lead final reconciliation, review, and archival of individual master files, working closely with Clinical Documentation Associates (CDAs), CDC leadership, and other stakeholders (e.g., CPD, SM&M, DSS, BSO).
• Support CRO-managed study TMFs, including quality checks of artifacts, uploading/classifying, and coordinating transfers of CRO TMFs into client’s eTMF system.
• Provide audit and inspection preparation support for paper and electronic TMFs: conduct data integrity checks, analyze TMF completeness, follow up on outstanding items, and complete pre-inspection requests.
• Act as subject matter expert during inspections, supporting eTMF system navigation, responding to auditor/inspector requests, and providing documentation as needed.
• Participate in TMF conversion and transfer activities from CROs or other external entities.
• Review regulatory document packages for Investigational Product (IP) release, work with Artifact Owners to resolve discrepancies, and provide approval for release to investigator sites.
• Contribute to continuous improvement by suggesting enhancements for work instructions, job aids, and participating in functional area initiatives.
• Ensure full compliance with GCP, client SOPs, and established processes