Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements
Job Summary
Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements.
Manage the progress of assigned studies by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Matching Summary
Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements.
Skills & Requirements
Must-have
Perform site monitoring visits
Administer protocol and study training
Evaluate study site quality and integrity
Manage study progress and documentation
Ensure TMF and ISF maintenance
Nice-to-have
Enhance predictability of subject recruitment
Collaborate with study team members
Effective time and financial management
Key Requirements
At least 3 years on-site monitoring experience
CRA Certification according to Ministerial Decree dated 15.11.2011
Good knowledge of GCP and ICH guidelines
Bachelor's and Master's Degree in scientific discipline or health care