(Sr) Clinical Research Specialist

Job description

·  Job facts

You will be responsible for:

·  Participates in the design, planning, implementation and overall direction of clinical research projects; may contributes technical and clinical operation expertise (if apply).
·  Plan and prepares studies, under supervision (if apply), including but not limited to site qualification, regulatory submission (e.g. HGRAC, EC and/or NMPA), study supply, site initiation, routine monitoring and close-out activities.
·  If, apply reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents.
·  If apply, works with Data Management and Biostatistics staffs on the design of documents and processes for the collection of study data from participating sites.
·  Collects and maintains legal and regulatory documentation throughout a study.
·  Assumes responsibility for training and coordinating certification of study site personnel.
·  Ensures accurate and complete study management/data collection and transfer to data management
·  Ensures study conduct and execution at site compliance with regulations and study protocol, and timely escalate identified risks/issues to investigator, project responsible and line manager for resolution. Implement CAPAs (as apply).
·  Conducts reference material testing in-house and rganizes investigator meetings, as necessary.

You should have:

·  At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology.
·  Proficiency in English language skills.
·  Good command of MS office software application.
·  Understand pharmaceutical and/or medical device regulation and ICH/GCP.
·  At least 2 years of working experience in clinical research, clinical project management, data management in clinical medicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries.
·  Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation.
·  Approximately 30% of time local and/or international travel.
·  According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.

罗氏是一家提供均等机会的雇主。
Research & Development、 Research & Development > Clinical Operations

·  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。