Clinical Research Associate

DOCS in Copperas Cove, TX

  • Industry: Pharmaceutical/Biotechnology - Others
  • Type: Full Time
position filled
To plan, execute and support clinical site management activities To ensure the quality and integrity of the data collected in clinical trials in accordance with the approved protocol, SOPs, ICH/GCP and regulatory requirements. To support the needs of internal and external clients or stakeholders. Roles & Responsibilities Conduct clinical trial site visits including evaluation, initiation, monitoring and close out Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems Build and maintain solid and professional relationships with site staff Facilitate subject enrollment incorporating recruitment strategies and action plans at site level Maintain site audit/inspection readiness Ensure appropriate safety reporting and use of on-line safety reporting/reviewing systems Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan Respond to site queries and escalate issues in accordance with processes and timelines Conduct IP accountability and reconciliation Facilitate implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting) Maintain site study supplies

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