Ensure that all clinical operations comply with the trial protocol, SOPs, ICH-GCP/China GCP and relevant regulatory requirements, and report all deviations in a timely manner.
Be responsible for the selection and evaluation of clinical trial sites, ensuring that the sites possess corresponding qualifications and meet the requirements of the trial protocol and the company.
Participate in the preparation and support work of investigator meetings.
Be responsible for submitting documents to the Institutional Review Board (IRB), obtaining ethical approvals/acknowledgments in a timely manner, and ensuring that the content complies with relevant regulations.
Complete the contract negotiation, signing and fee management of clinical trial sites; apply for and make payment of trial funds on schedule, and collect invoices in a timely manner.
Be responsible for the initiation, routine and close-out monitoring of clinical trial sites, and submit monitoring reports on time.
Bachelor's degree or above in Medicine, Pharmacy or other related majors.
Familiar with ICH-GCP and relevant regulations.
At least 3 years of work experience as a Clinical Research Associate (CRA), with project experience in the field of oncology and metabolic disease treatment preferred.
Candidates with working experience in biopharmaceutical enterprises, foreign-funded enterprises or overseas background are preferred.