Project Specialist of Clinical Research
Job Responsibilities
- Assist monitoring project progress, quality, protocol execution.
- Participate in the development of overall clinical research plans and clinical trial protocols.
- Assist in the screening and evaluation of clinical trial centers, CROs, SMOs, and other suppliers.
- Assist in the writing, review, and finalization of clinical trial protocols, original medical records, CRFs, clinical trial operation manuals, laboratory operation manuals, and clinical trial reports and other related technical documents.
- Coordinate and complete internal audits and quality assurance for clinical trial projects.
Job Requirements
- Have a background in medicine, pharmacy, life sciences, bachelor's degree or above, proficient in English.
- Have a good understanding of relevant regulations such as ICH-GCP Guidelines and \Drug Clinical Trial Quality Management Regulations\, and have a good knowledge reserve in all aspects of clinical trials.