Regulatory Compliance Specialist

2 weeks ago


kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time
About the Role

The Clinical Research Associate will be responsible for performing site monitoring visits to ensure compliance with contracted scope of work and regulatory requirements.

Main Accountabilities
  • Conduct site initiation visits to ensure understanding of the protocol and related procedures.
  • Monitor study sites to ensure adherence to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Track and report on site performance and compliance with regulatory requirements.
  • Collaborate with study team members to resolve project execution issues.
Requirements
  • Bachelor's Degree in a scientific discipline or healthcare preferred.
  • At least 1 year of on-site monitoring experience.
  • Good knowledge of clinical research regulatory requirements and therapeutic areas.
  • Excellent communication and interpersonal skills.


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