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In-House Clinical Research Associate
Job in
Bethesda, Montgomery County, Maryland, 20811, USA
Listed on 2026-09-21
Listing for:
Piper Companies
Full Time
position Listed on 2026-09-21
Job specializations:
-
Research/Development
Clinical Research
Job Description & How to Apply Below
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:- 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
This job is open for applications on August 12th, 2026. Applications will be accepted at least 30 days from the posting date.
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Position Requirements
10+ Years
work experience
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