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.