In-House Clinical Research Associate

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 Qualifications: for the In-House Clinical Research Associate include: · 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: for In-House Clinical Research Associate includes: · Rate Range: $50,000-$80,000, depending on experience · Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law This job is open for applications on August 12th, 2026. Applications will be accepted at least 30 days from the posting date.