Clinical Research Associate I

2 meses atrás


Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiro
Job Responsibilities

As a Senior Clinical Research Associate I at Syneos Health, Inc., you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance. You will use your judgment and experience to evaluate the overall performance of sites and site staff, providing recommendations for site-specific actions. You will immediately communicate and escalate serious issues to the project team and develop action plans.



Key Tasks


  • Perform site qualification, site initiation, interim monitoring, site management, and close-out visits
  • Evaluate site performance and provide recommendations for site-specific actions
  • Communicate and escalate serious issues to the project team and develop action plans
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
  • Assess factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site
  • Conduct Source Document Review of appropriate site source documents and medical records
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
  • Apply query resolution techniques remotely and on site
  • Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
  • Verify site compliance with electronic data capture requirements


Requirements

You should have a Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements is essential. You must demonstrate good computer skills and be able to adapt to new technologies. Excellent communication, presentation, and interpersonal skills are required. Ability to manage required travel of up to 75% on a regular basis is also necessary.



About Syneos Health, Inc.

Syneos Health, Inc. is a leading biopharmaceutical solutions organization. We are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.



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