Piper Clinical Solutions is currently hiring for a In House CRA in the Montgomery County area. This is a contract to hire opportunity with a great mid-sized pharmaceutical company!
4+ years of experience as a In House CRA, or monitor required.
Bachelors degree Required
Reviews site regulatory documents and maintains required study files
Review Lab Reconciliation Documents and Reconciliation Documents for database locks
Strong understanding of lab samples and PLC Samples
Strong understanding of and experience with study tracking for study supplies
Review documentation of trials including but not limited to assessing site performance, tracking study drug and other study-specific material shipments to/from sites.
Assures regulatory compliance of investigational sites with company SOPs, FDA, and ICH guidelines
Resolves site-specific study issues by working with study staff and with CROs, as applicable. Monitors electronic data capture (EDC) systems including reviews for completeness and consistency. Generates and resolves queries in clinical data with clinical sites and/or through a CRO, ensuring proper reporting of Adverse Events and appropriate follow-up
Contributes to the safety review process of ongoing clinical trials. Ensures proper reporting Adverse Events (AEs) and Serious Adverse Events (SAEs), coordinates presentation of information to Data Safety Monitoring Committees. Ensures timely notification to the appropriate Company and/or CRO clinical/regulatory staff and local IRB/IECs, as applicable.
Assists with designing study documents including, but not limited to, case report forms, site study procedure manuals and source documents/worksheets, monitoring plans, tracking tools, and informed consent forms
Supports clinical operations by ensuring trials are completed on time and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP
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