Clinical Operation Intern
Internship Shanghai, CHINA Teaching
Job description
· Job facts
Primary Purpose of Job (Job Summary)
1. Scanning Hub Support
· Review and scan the clinical trial related documents with high quality according to the scanning hub requirements and upload to required system within required timeline.
· Maintain local scanning hub public mailbox in a timely manner including review, reply and archive important communication.
· Maintain the local scanning status tracker daily to ensure all documents could be scanned and uploaded within required timeline.
· Answer and resolve any query from global scanning hub responsible, CDC.
· Provide support and input to improve the local process of scanning if needed.
2. Clinical Trial Document Archiving
· Be familiar with the content of clinical trial master file and investigator site file based on the requirements of ICH GCP, China regulation and Roche SOPs, guidance.
· Review the closed clinical trial documents, support archiving responsible to arrange and archive them according to related SOP requirements.
3. Business Support to Department
· Understand ICH GCP, China GCP and related regulation on clinical trials, especially on Ethic Committee (EC) requirements for study initiation.
· Support SSUS to prepare the essential EC submission package according to required timeline.
4. General Office Duties
· Provide general office support to PDG CCO department staff (including but not limited to photocopying, distributing mail/faxes, scanning, faxing,).
· Organize courier services for documents/ goods pick-up.
· Administrative supports on the activities assigned by line manager
Qualification and Experience
1. Education/Qualifications
· Bachelor degree preferred (4th year student)
· Major in Pharmacy or medical related
2. Personality
· Good ownership and focus on details
· Logical and efficient with highly compliance
· Be willing to learn, think and practice
3. Job Required Competencies
· Good Computer skill for Window 7, Microsoft 2010 (PPT, Excel, Word)
· Strong communication skills
· Fluent English written and oral capability
罗氏是一家提供均等机会的雇主。
职业与发展计划、 职业与发展计划 > 实习
· Who we are
在罗氏,来自100个国家的98,000名员工不断推动着健康医疗行业的进步。我们一同工作,使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化,也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域,罗氏设定了远大的计划,坚持学习和发展,并不断寻找与之志同道合的伙伴。
罗氏提供平等的职业发展机会。