In-House Clinical Research Associate

Job Summary:

Piper Companies is seeking an In-House Clinical Research Associate to support a clinical research organization providing clinical trial management and regulatory support services. This position is hybrid in Bethesda, MD, with 2 days onsite and 3 days remote per week.

Responsibilities for the In-House Clinical Research Associate include:

• Review and process essential regulatory documents received from clinical trial sites.
• Maintain and organize Trial Master Files (TMF) within electronic document management systems.
• Track regulatory documents and study records in centralized web-based databases.
• Evaluate documentation for completeness and compliance with FDA, ICH-GCP, sponsor, and SOP requirements.
• Coordinate the collection of missing or incomplete site regulatory documentation.
• Assist with study start-up, monitoring visit preparation, and follow-up activities.
• Collaborate with CRAs, project managers, site personnel, and sponsors to support ongoing clinical trial operations.

Required Qualifications for the In-House Clinical Research Associate include:

• Bachelor's degree in a health-related field or Licensed Practical Nurse (LPN) credential.
• 2-5 years of experience within a clinical research, pharmaceutical, CRO, sponsor, or clinical site environment.
• Experience reviewing and collecting regulatory documents in support of clinical trials.
• Specialized experience with eTMF systems such as Veeva Vault and associated system administration activities.
• Knowledge of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
• Strong proficiency with Microsoft Office, including Word, Excel, and Outlook.

Preferred Qualifications for the In-House Clinical Research Associate include:

• Experience with IRB submissions and OHRP regulations.
• Previous experience as a CRA, Study Coordinator, IRB Coordinator, or Regulatory Specialist.
• Experience maintaining Trial Master Files within sponsor or CRO environments.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.

Compensation for the In-House Clinical Research Associate includes:

• Salary Range: $50,000-$80,000 annually
• Full Benefits Package: Provided in interview process

This Job opens for applications on 10/9/2026. Applications for this job will be accepted for at least 30 days from the posting date