In-House Clinical Research Associate
Piper Companies · Bethesda, MD · Today
Hybrid$50k–$80k/yrFull-time
About the role
Piper Companies is seeking an In-House Clinical Research Associate to support a clinical research organization in Bethesda, MD.
Responsibilities
- 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
- 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
- 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
- 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