Purpose of Job
Accountable for the study start-up timelines and delivery, with high quality and according to ICH/GCP
Major Responsibilities
Delivery of clinical start-up component of assigned studies with accountability for time, cost and quality for assigned activities, which include, but not limited to,
o Investigator/Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study
o Prepare IRB submission
o Clinical trial site contract and budget negotiation, if required
o Prepare, submit regulatory documents to HGRAC and obtain approval for required study
? Assist in maintain and update company-level investigator database
? Establish, maintain and enhance relationship with key opinion investigators and sites
? Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside start-up team. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans
? Perform other duties as assigned by management
职位要求：
Qualification
Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
? Knowledgeable in the execution of clinical trials, understanding of GCP/ICH Guidelines and other applicable regulatory requirements
? At least 3 year of clinical research experience in the Pharmaceutical or CRO industry
? Self-motivation with the ability to work under pressure to meet deadlines
? Fluent in English (writing and speaking)