Hybrid In-House CRA — Regulatory & TMF Support

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

Benefits offered by this job

Full Benefits Package

Job summary

Piper Companies is seeking an In-House Clinical Research Associate to support clinical trial management and regulatory tasks. The role is hybrid in Bethesda, MD, with a mix of 2 days onsite and 3 days remote weekly.

The candidate will review regulatory documents, manage TMF, and coordinate missing documents while ensuring FDA/ICH-GCP compliance. Collaboration with CRAs, PMs, site staff, and sponsors is essential.

Qualifications

• Bachelor’s degree in a health-related field or LPN credential.
• 2-5 years of experience in clinical research or related settings.
• Experience reviewing regulatory documents for trials.
• Experience with eTMF systems such as Veeva Vault and related admin tasks.
• Knowledge of FDA regulations, ICH-GCP, and trial compliance requirements.
• Proficient in Word, Excel, and Outlook.

Responsibilities

• Review and process regulatory documents from trial sites.
• Maintain and organize TMF within electronic systems.
• Track regulatory documents and study records in databases.
• Evaluate documentation for FDA/ICH-GCP compliance.
• Coordinate collection of missing regulatory docs.
• Assist with study start-up, monitoring, and follow-up activities.
• Collaborate with CRAs, PMs, site staff, and sponsors.

Skills

Clinical research experience

Regulatory knowledge

Regulatory document review

eTMF familiarity

Education

Bachelor’s degree in health field

LPN credential

Tools

Veeva Vault

Microsoft Office

Job description

Piper Companies is seeking an In-House Clinical Research Associate to support clinical trial management and regulatory tasks. The role is hybrid in Bethesda, MD, with a mix of 2 days onsite and 3 days remote weekly.

The candidate will review regulatory documents, manage TMF, and coordinate missing documents while ensuring FDA/ICH-GCP compliance. Collaboration with CRAs, PMs, site staff, and sponsors is essential.