What are the responsibilities and job description for the In-House Clinical Research Associate position at Piper Companies?
Piper Companies is currently looking for an In-House Clinical Research Associate in the Bethesda, MD area to work a hybrid role. The In-House Clinical Research Associate will join a mission-driven organization focused on delivering research, technical, and operational solutions that help advance healthcare innovation.
Responsibilities for the In-House Clinical Research Associate:
TMF, eTMF, Veeva Vault, Regulatory Coordinator, Regulatory Specialist, Clinical Trial Assistant, Clinical Research Coordinator, IRB, GCP, ICH, Clinical Operations, Document Control, and Regulatory Documentation, Tracking and Reporting, Documentation Review, IRB Coordinator, CTA, CRC, CRA, TMF Specialist, FDA Regulations, Regulatory Affairs
Responsibilities for the In-House Clinical Research Associate:
- 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.
- 3-5 years of clinical research experience, including document management and electronic systems support.
- Experience reviewing and maintaining regulatory documentation in a 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.
- Salary range: $50,000-80,000 based on professional experience
- Comprehensive Benefits: Medical, Dental, Vision, 401K, and Sick Leave as required by law
TMF, eTMF, Veeva Vault, Regulatory Coordinator, Regulatory Specialist, Clinical Trial Assistant, Clinical Research Coordinator, IRB, GCP, ICH, Clinical Operations, Document Control, and Regulatory Documentation, Tracking and Reporting, Documentation Review, IRB Coordinator, CTA, CRC, CRA, TMF Specialist, FDA Regulations, Regulatory Affairs
Salary : $50,000 - $80,000