Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Consulting, Contract Research Organization (CRO), Document Management, FDA Requirements, File Maintenance, GCP (Good Clinical Practices), Healthcare, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Licensed Practical Nurse/Licensed Vocational Nurse, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Multitasking, Organizational Skills, Regulations, Regulatory Compliance, Regulatory Submissions, Startup, Support Documentation, Systems Administration/Management, Time Management
Job Summary:
Piper Companies is seeking an In-House Clinical Research Associate to support a clinical research organization in Bethesda, MD.
Responsibilities for the In-House Clinical Research Associate include:
- Review and process essential regulatory documents received from clinical trial sites.
- Maintain and organize Trial Master Files (TMF) within electronic document management systems.
- Track regulatory documents and study records in centralized web-based databases.
- Evaluate documentation for completeness and compliance with FDA, ICH-GCP, sponsor, and SOP requirements.
- Coordinate the collection of missing or incomplete site regulatory documentation.
- Assist with study start-up, monitoring visit preparation, and follow-up activities.
- Collaborate with CRAs, project managers, site personnel, and sponsors to support ongoing clinical trial operations.
Required Qualifications for the In-House Clinical Research Associate include:
- 3-5 years of experience within a clinical research, pharmaceutical, CRO, sponsor, or clinical site environment.
- Bachelor's degree in a health-related field or Licensed Practical Nurse (LPN) credential.
- Experience reviewing and collecting regulatory documents in support of clinical trials.
- Specialized experience with eTMF systems such as Veeva Vault and associated system administration activities.
- Knowledge of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
- Strong proficiency with Microsoft Office, including Word, Excel, and Outlook.
Preferred Qualifications for the In-House Clinical Research Associate include:
- Experience with IRB submissions and OHRP regulations.
- Previous experience as a CRA, Study Coordinator, IRB Coordinator, or Regulatory Specialist.
- Experience maintaining Trial Master Files within sponsor or CRO environments.
- Strong organizational skills with the ability to manage multiple priorities and deadlines.
Compensation for the In-House Clinical Research Associate includes:
- Salary Range: $50,000-$80,000 annually depending on experience
- Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset
This Job opens for applications on 6/24/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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Keywords:
In-House Clinical Research Associate, Clinical Research Associate, CRA, Clinical Trials, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Clinical Operations, FDA Regulations, ICH-GCP, GCP Compliance, IRB Submissions, OHRP Regulations, Clinical Research Organization, CRO, Study Coordinator, Regulatory Coordinator, Regulatory Specialist, Pharmaceutical Research, Healthcare Industry, Clinical Documentation, Microsoft Office, Contract-to-Hire, Clinical Study Support, Sponsor Studies, Site Management, Regulatory Compliance