In-House Clinical Research Associate — Regulatory & TMF

Piper Companies; Bethesda (MD); On-site; USD 50,000 - 80,000; Full time

Benefits offered by this job

Cigna Medical/Dental/Vision

401K

Sick Leave as Required by Law

Job summary

Piper Companies is seeking an In-House Clinical Research Associate located in Bethesda, MD. The role involves reviewing and processing regulatory documents, maintaining Trial Master Files, and ensuring compliance with FDA and ICH GCP guidelines. Ideal candidates will have 3-5 years of experience in clinical research and a Bachelor’s degree. The compensation ranges from $50,000 to $80,000, along with a comprehensive benefits package, including medical, dental, vision, and a 401K plan.

Qualifications

• 3–5 years of experience in a clinical research setting.
• Knowledge of FDA and ICH GCP guidelines.
• Experience with IRB submissions is a plus.

Responsibilities

• Review and process essential regulatory documents.
• Maintain and organize Trial Master Files.
• Track regulatory documents in a centralized system.

Skills

Regulatory document review

Experience with eTMF systems

Strong organizational skills

Communication skills

Time management

Proficiency with Microsoft Office

Education

Bachelor’s degree

Tools

Veeva Vault

Job description

Piper Companies is seeking an In-House Clinical Research Associate located in Bethesda, MD. The role involves reviewing and processing regulatory documents, maintaining Trial Master Files, and ensuring compliance with FDA and ICH GCP guidelines. Ideal candidates will have 3-5 years of experience in clinical research and a Bachelor’s degree. The compensation ranges from $50,000 to $80,000, along with a comprehensive benefits package, including medical, dental, vision, and a 401K plan.