In-House Clinical Research Associate

Piper Companies is looking for an In-House Clinical Research Associate to join a clinical research company located in Bethesda, MD . Responsibilities 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 Qualifications 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) Compensation Rate Range: $50,000–$80,000, depending on experience Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law #J-18808-Ljbffr