1. Performing project screening, initiation, monitoring and close-out of study sites under the guidance of the project manager;
2. Responsible for monitoring the clinical trials to ensure the clinical trials perform in accordance with the clinical protocol, standard operating procedure (SOP), good clinical practice (GCP) and applicable laws and regulations;
3. Responsible for the organization and completion of all trial-related documents and materials, submitting monitoring reports; reporting trial progress and quality to the project manager in a timely manner, including the completion of Case Report Forms (CRFs), the usage of study drugs, adverse drug reactions, etc. Identifying and analyzing issues, proposing solutions and implementing them;
4. Following up on AE’s and SAE’s during trials and protecting the rights of subjects;
5. For outsourced projects, coordinating with CRO’s and study sites to set up and maintain good relationships.
1. Bachelor’s degree or above, with major related to medicine, pharmaceutical sciences, clinical medicine, nursing, etc.;
2. Have a GCP training certificate, with at least 3 years of CRA work experience, those with experiences in phase I clinical trial monitoring of antineoplastic drugs preferred;
3. Familiar with provisions for drug registration, GCP regulations and relevant regulations for clinical studies;
4. Good written and verbal communication skills, including English reading and writing;
5. Ability to communicate, coordinate, and execute plans in a team setting.