What are the responsibilities and job description for the In-House Clinical Research Associate position at Piper Companies?
Piper Companies is looking for an In-House Clinical Research Associate to join a clinical research company located in Bethesda, MD.
Responsibilities of the In-House Clinical Research Associate include:
Keywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook
Responsibilities of the In-House Clinical Research Associate include:
- Review and process essential regulatory documents received from clinical trial sites
- Request missing or additional documentation and respond to protocol or process-related inquiries
- Maintain and organize Trial Master Files (TMF) and centralized document systems
- Track regulatory documents and workflow in a centralized web-based system or database
- Ensure documents meet FDA, ICH GCP, and sponsor requirements for accuracy and completeness
- Troubleshoot regulatory document issues and follow up with study sites as needed
- Support distribution of trial-related materials and assist with study team coordination
- Assist with monitoring visit preparation and follow-up, including teleconference coordination
- 3–5 years of experience in a clinical research setting
- Experience with regulatory document review/collection and knowledge of FDA and ICH GCP guidelines
- Experience with eTMF systems (e.g., Veeva Vault) and system administration skills
- Experience with Trial Master Files and centralized tracking systems
- Experience with IRB submissions and OHRP regulations is a plus
- Bachelor’s degree required
- Strong organizational, communication, and time management skills
- Proficiency with Microsoft Office (Word, Excel, Outlook)
- Rate Range: $50,000–$80,000, depending on experience
- Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
Keywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook
Salary : $50,000 - $80,000