Main Accountabilities:

• To ensure all related clinical research operations and procedures are in compliance with protocol, Amador’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

• To be responsible for clinical study sites selection and to ensure these sites can meet the Amador’s requirements and qualified with NMPA.

• To be responsible for clinical trail start-up at sites, include complete GCP submission, obtain the EC approval, and support for the OHGRA application and approval, contract negociation and sign-off.

• To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time.

• To be responsible for submitting documents to site GCP office & EC correctly and on time.

• To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, Amador’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

• To be responsible for using CTMS or required system and trackers in clinical trial and ensure information entered into CTMS or required system and trackers is accurate and updated regularly

• To ensure AEs/SAEs are recorded correctly and reported approprately according to timeline stipulated in clinical study protocols and current regulation.

• To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time.

• To be responsible for transfer Amador study essential documents to TMF on time and consist with ISF.

• To build and keep good working relationship with clinical study sites.

• To be able to complete the above tasks independently with satisfaction.

Role Related Qualifications/ Skills:

• 1-2 years of CRA experience in a CRO or pharmaceutical & medical device company.

• Bachelor’s degree or above in Medical, Pharmacy or related areas.

• Comprehensive knowledge and understanding of ICH-GCP/Chinese GCP and applicable local regulations.

• Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site staffs.

• Fine written, verbal skills, and presentation skills in both Chinese and English

上班地址：浙江省杭州经济技术开发区白杨街道科技园路2号1幢504-506室