This position serves as a Clinical Research Associate / Clinical Trial Manager in our Hangzhou China office.
Primary Duties and Responsibilities:
- Prepare and organize meetings;
- EC communication, submit and track EC approval;
- Facilitate the contracting process by negotiating and signing contracts with the relevant institutions, investigators and other clinical study personnel;
- Provide study progress report, perform routine monitoring visits and provide monitoring visit reports;
- Ensure all data records and reports are completed correctly and consistent with source documents;
- Ensure all AEs are well-documented, and SAEs are reported and archived according to regulatory requirements;
- Verify and document whether investigational products are supplied, stored, distributed and returned per requirements.
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required;
- A minimum of 2 years of clinical trial monitoring experience is preferred;
- Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines;
- Good written and oral communication;
- Fluent in both Chinese and English.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.