Clinical Research Associate II

il y a 4 semaines


Nantes, Pays de la Loire, France Pharmiweb Temps plein
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team in a Sponsor Dedicated role. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities
  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
  • Assess factors that might affect subject/patient's 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.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
Requirements
  • 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.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.



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