Senior Clinical Research Associate in Oncology

15 hours ago


Gold Coast, Queensland, Australia Pharmiweb Full time
Job Title: Senior Clinical Research Associate in Oncology

Join Syneos Health, a leading biopharmaceutical solutions organization, as a Senior Clinical Research Associate in Oncology. In this role, you will be responsible for managing clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.

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.


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