Clinical Documentation Specialist II at US Tech Solutions California

Us Tech Solutions; California; On-site; USD 70,000 - 95,000; Full time

Job summary

US Tech Solutions is hiring a Clinical Documentation Specialist II to work remotely from California. The role involves managing study activities from Phase I to IV, ensuring Master File compliance with ICH GCP guidelines, and promoting awareness of clinical documentation procedures.

The ideal candidate will have a bachelor’s degree, at least 2 years of relevant experience, and strong analytical and communication skills. Proficiency in Microsoft PowerPoint, Excel, and document management systems is also essential.

Qualifications

• Minimum of 2 years of relevant industry experience in clinical document management.
• Demonstrated analytical and critical thinking skills.
• Excellent oral and written communication skills.

Responsibilities

• Manage Phase I to IV study activities.
• Ensure the Master File is inspection-ready and compliant with ICH GCP guidelines.
• Facilitate cross-functional team meetings and promote awareness of clinical documentation business procedures.

Skills

Analytical skills

Communication skills

Knowledge of clinical documentation processes

Microsoft PowerPoint

Microsoft Excel

Education

Bachelor’s degree or international equivalent

Tools

Document Management Systems

Job description

Position Overview

Clinical Documentation Specialist II at US Tech Solutions, California, 100% remote.

Responsibilities

• Manage Phase I to IV study activities.


• Ensure the Master File is inspection‑ready and compliant with ICH GCP guidelines, maintaining key Master File health indicators (completeness, accuracy, timeliness) throughout the lifecycle of assigned clinical trials.


• Update and assist study teams to address issues related to Master File health indicators.


• Facilitate cross‑functional team meetings and promote awareness of clinical documentation business procedures.

Qualifications

• Bachelor’s degree (or international equivalent) with a minimum of 2 years of relevant industry experience in clinical document management or a related role.


• Demonstrated analytical and critical thinking skills.


• Excellent oral and written communication skills.


• Knowledge of clinical documentation processes and business procedures.


• Proficiency with Microsoft PowerPoint, Excel, and/or Document Management Systems.

EEO Statement

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.