Hybrid In-House CRA: Regulatory & TMF Expert

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

Benefits offered by this job

Full benefits package

Tuition reimbursement

Paid time off

Job summary

Piper Companies is seeking an In-House Clinical Research Associate to support a CRO providing clinical trial management and regulatory services. The role is hybrid in Bethesda, MD, with two days onsite and three days remote per week.

The ideal candidate has a health-related degree or LPN, 2–5 years in a CRO/clinical setting, and hands-on experience with FDA/ICH-GCP compliance and Veeva Vault/eTMF systems. Proficiency in Microsoft Office is required.

Qualifications

• Bachelor's degree in a health-related field or LPN credential.
• 2–5 years of experience in clinical research, pharma, CRO, sponsor, or site environment.
• Experience reviewing and collecting regulatory documents for clinical trials.
• Specialized experience with eTMF systems such as Veeva Vault and related admin activities.
• Knowledge of FDA regulations, ICH-GCP, and compliance requirements.
• Strong proficiency with Microsoft Office (Word, Excel, Outlook).

Responsibilities

• Review and process essential regulatory documents from trial sites.
• Maintain and organize TMF within electronic document systems.
• Track regulatory documents and study records in centralized databases.
• Evaluate documentation for completeness and compliance with FDA/ICH-GCP/sponsor/SOPs.
• Coordinate collection of missing or incomplete site regulatory docs.
• Assist with study start-up, monitoring visit prep, and follow-up activities.
• Collaborate with CRAs, PMs, site personnel, and sponsors to support trial operations.

Skills

Regulatory compliance

Documentation management

Microsoft Office

Education

Bachelor's degree in health-related field

Licensed Practical Nurse (LPN) credential

Tools

Veeva Vault

eTMF systems

Job description

Piper Companies is seeking an In-House Clinical Research Associate to support a CRO providing clinical trial management and regulatory services. The role is hybrid in Bethesda, MD, with two days onsite and three days remote per week.

The ideal candidate has a health-related degree or LPN, 2–5 years in a CRO/clinical setting, and hands-on experience with FDA/ICH-GCP compliance and Veeva Vault/eTMF systems. Proficiency in Microsoft Office is required.