Onsite Clinical Research Associate - Regulatory & TMF

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

Benefits offered by this job

Health/Dental/Vision

401K

Sick leave as required by law

Job summary

Piper Companies in Bethesda, MD is seeking an In-House Clinical Research Associate to join a clinical research organization.

The CRA will review regulatory documents, manage TMF, support site coordination and be versed in FDA/ICH GCP requirements. Bachelor's degree required and 3–5 years of CRA experience preferred.

Experience with eTMF systems such as Veeva Vault and IRB submissions is a plus; competitive benefits offered.

Qualifications

• Bachelor’s degree required.
• 3–5 years in clinical research.
• Experience with regulatory document review and FDA/ICH GCP.
• Experience with eTMF systems (Veeva Vault) and system administration.
• Strong organizational and time management.
• Proficiency with Microsoft Word/Excel/Outlook.
• Experience with IRB submissions is a plus.

Responsibilities

• Review and process regulatory documents from trial sites.
• Request missing documentation and respond to protocol inquiries.
• Maintain and organize Trial Master Files (TMF).
• Track regulatory documents in centralized systems.
• Ensure documents meet FDA/ICH GCP and sponsor requirements.
• Troubleshoot regulatory document issues with study sites.
• Support distribution of trial materials and study team coordination.
• Assist with monitoring visit prep and teleconference coordination.

Skills

Regulatory documents review

FDA/ICH GCP knowledge

eTMF systems (Veeva Vault)

TMF management

IRB submissions knowledge

Microsoft Office

Organizational & time management

Communication skills

Education

Bachelor’s degree

Tools

Veeva Vault

TMF tracking systems

Job description

Piper Companies in Bethesda, MD is seeking an In-House Clinical Research Associate to join a clinical research organization.

The CRA will review regulatory documents, manage TMF, support site coordination and be versed in FDA/ICH GCP requirements. Bachelor's degree required and 3–5 years of CRA experience preferred.

Experience with eTMF systems such as Veeva Vault and IRB submissions is a plus; competitive benefits offered.