In-House Clinical Research Associate

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. 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.