Clinical Monitor (WRAIR)
Walter Reed Army Institute of Research (WRAIR), in support of its biomedical research mission, has a requirement to support the Center for Military Psychiatry and Neurosciences (CMPNS) mission to conduct basic and applied research to develop evidence-based strategies to diagnose, prevent, and mitigate the effects of psychological demands, continuous operations, and brain trauma on the health and well-being of Service Members. The position outlined below is in support of the Behavioral Biology Branch.Responsibilities:
- Prepare and send visit confirmation letter to site, review relevant information including, but not limited to, previous visits, review protocols and essential documents, and Standard Operating Procedures (SOPs).Conduct site visits as dictated by the monitoring plan, to:
- Verify Source Data (100% of subjects/100% of Data) including: entry criteria, informed consent (ICF) process verification (review ICFs on all subjects identified), essential regulatory document review and ICF contents, primary efficacy and safety endpoints, serious adverse events, clinical event endpoints with review and collection of adjudication documentsReview investigator files, and communicate with site Investigator/coordinator any issues that require follow up, action(s) to be taken, and expected timelines for completion for all action items.
- Complete the monitoring follow up letter sent to Investigator outlining the pertinent points discussed, and the agreed upon action items.Provide documentation of visit by a trip report in an agreed upon format, and subsequent written summaries of follow up communications within 30 business days of visit.Use Close Out Visit guidelines to verify the completeness of the site file and Close out procedures, assist with any final questions regarding the data collected, review final Case Report Forms (CRFs) and verify that all corrections were made, provide information and assistance to the site center regarding study records retention, provide information and assistance with handling potential FDA inspections, and monitor site data quality and query status, and assist with data and query resolution, as the studies will be conducted via Electronic Data Capture and/or paper Case Report Forms.
- Requires a BS, RN, or BSN degree or equivalent and 0-3 years of experience in the field or in a related area.
- Knowledge of commonly-used concepts, practices, and procedures in a clinical research setting.Knowledge of FDA regulatory requirements is required.