Clinical Documentation Specialist II

The Fountain Group is currently seeking a Clinical Documentation Specialist II  for a prominent client of ours. This position is located in Lake County, North Chicago, IL . Details for the position are as follows:

Job Title: Clinical Documentation Specialist II
Location: Lake County, North Chicago, IL – Hybrid Preferred
Pay Rate: $41–$38/hr
Duration: 1 year

Job Description

• Manage and maintain Trial Master File (TMF) documentation to ensure inspection readiness and compliance with ICH GCP requirements.

• Perform TMF quality checks and monitor completeness, accuracy, timeliness, and document quality throughout clinical trial lifecycles.

• Partner with document owners and cross-functional study teams to resolve filing and documentation quality issues.

• Monitor TMF health metrics, identify trends and risks, and implement mitigation strategies.

• Prepare TMF oversight reports, quality assessment reports, presentations, and stakeholder updates.

• Support finalization and archival of study Master Files within electronic TMF systems.

• Support audit and regulatory inspection preparation activities.

• Review SOPs, work instructions, and job aids and contribute to process improvement initiatives.

• Perform QC checks on internal and external document processing activities.

Education

• Bachelor’s degree or international equivalent preferred.

• 4+ years of relevant clinical document management or equivalent clinical research experience.

• Without a bachelor’s degree, 6+ years of relevant clinical research experience.

Required Skills

• Clinical document management and Trial Master File (TMF) experience.

• Electronic Trial Master File (eTMF) systems.

• ICH GCP and clinical documentation processes.

• TMF quality control and inspection-readiness activities.

• TMF health metrics, oversight, and quality assessments.

• Clinical documentation gap identification and issue resolution.

• Microsoft Excel and PowerPoint.

Preferred Skills

• Experience supporting clinical audits and regulatory inspections.

• Experience developing SOPs, work instructions, and job aids.

• Experience with TMF process improvement initiatives.

• Experience conducting QC reviews of clinical documentation.

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