In-House Clinical Research Associate - 174534 - 176084
Company: Piper Companies Agency
- Location: Bethesda, United States
- Work mode: Hybrid
- Employment type: Full-time
- Posted: 10 days ago
- Offer language: English
Job description
Job Summary:
Piper Companies is seeking an In-House Clinical Research Associate to support a clinical research organization providing clinical trial management and regulatory support services. This position is hybrid in Bethesda, MD, with 2 days onsite and 3 days remote per week.
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:
- Bachelor’s degree in a health-related field or Licensed Practical Nurse (LPN) credential.
- 2–5 years of experience within a clinical research, pharmaceutical, CRO, sponsor, or clinical site environment.
- 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
- Full Benefits Package: Provided in interview process
This Job opens for applications on 10/9/2026. Applications for this job will be accepted for at least 30 days from the posting date
