Responsibilities

To ensure the proper conduct and reporting of clinical research trials according to standard operating procedures (SOPs) and good clinical practice (GCP). (GCP includes the US federal regulations, International Conference on Harmonization (ICH) GCP and other applicable guidelines and regulations).

The specific responsibilities are as follows, but not limited to:

• Serve as a liaison between clinical trial sponsor(s) and sites
• Conduct site qualification, initiation, monitoring and close-out visits of moderate to complex clinical studies according to regulatory standards, SOPs and contract requirements
• Ensure compliance with protocol and overall clinical objectives
• Monitor investigator study files for compliance and accuracy

Qualifications

• Bachelor's degree in Biological Sciences, Nursing or equivalent preferred
• Minimum of 2 years of scientific/clinical research associate experience (CRA certification preferred)
• Knowledge of drug and/or device industry
• Knowledge of US federal regulations, ICH Guidelines and GCP

Posted On: Sunday, October 20, 2024