Hybrid In-House CRA - Documentation & Compliance

Zachary Piper Solutions

Bethesda (MD)

Hybrid

USD 50,000 - 80,000

Full time

6 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401K
Sick leave

Job summary

Piper Companies in Bethesda, MD is seeking an In-House Clinical Research Associate for a hybrid role to support regulatory documentation and site coordination across clinical projects.

You will review and manage project documents, maintain electronic records, monitor workflow status, and assist IRB submissions, with 3–5 years of clinical research experience and a science or health-related degree.

The position offers comprehensive benefits and supports ongoing healthcare innovation.

Qualifications

  • 3-5 years of clinical research experience
  • Experience reviewing and maintaining regulatory documentation in sponsor, CRO, research, or healthcare setting
  • Knowledge of clinical research regulations, compliance requirements, and documentation practices
  • Experience supporting IRB submissions or regulatory review processes preferred
  • Bachelor's degree in a science, health-related, or similar field

Responsibilities

  • Review and manage project documentation to ensure accuracy, completeness, and compliance.
  • Coordinate with sites and stakeholders to obtain missing information and resolve documentation-related inquiries.
  • Maintain organized electronic records, files, and tracking systems throughout the project lifecycle.
  • Monitor document status and workflow progress within centralized databases and internal platforms.
  • Support administrative and operational processes through accurate recordkeeping and data management.

Skills

Clinical research experience
Document management

Education

Bachelor's degree in science/health field

Tools

Veeva Vault
eTMF

Job description

Piper Companies in Bethesda, MD is seeking an In-House Clinical Research Associate for a hybrid role to support regulatory documentation and site coordination across clinical projects.

You will review and manage project documents, maintain electronic records, monitor workflow status, and assist IRB submissions, with 3–5 years of clinical research experience and a science or health-related degree.

The position offers comprehensive benefits and supports ongoing healthcare innovation.

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