Posted:4 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

 

  • Assist in setting up, initiating, monitoring, and closing clinical study sites.

  • Support in preparing essential documents (Trial Master File, Investigator Site File, etc.).

  • Verify that data entered in case report forms (CRFs) is accurate and complete.

  • Ensure site compliance with study protocol, GCP, and regulatory guidelines.

  • Assist in site communication, scheduling monitoring visits, and maintaining records.

  • Support in adverse event (AE/SAE) reporting and follow-up.

  • Coordinate with Clinical Data Management, Regulatory Affairs, and other departments as needed.

  • Maintain up-to-date knowledge of ICH-GCP guidelines and relevant regulatory requirements.

  • Participate in internal training sessions and workshops to enhance clinical research skills.

 

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