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As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.
Job Responsibility:
Oversight of monitoring responsibilities and study conduct
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites
Serve as the primary point of contact for assigned investigator sites
Conduct remote assessments of electronic-Diary (e-Diary) data
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes
Resolve data queries within required timelines
Ensure adequate oversight of the investigational product at the investigator site
Maintain thorough understanding of the product, protocol and therapy area
Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
Drive Quality Event (QE) remediation, when applicable
Serve as a point of contact for audit conduct
Requirements:
Minimum 1 year relevant experience in clinical research site monitoring and management
Knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Significant travel (60-80%) within area is required
Nice to have:
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases