上海招聘

The Senior Clinical Research Associate (SCRA) has the responsibilities for the successful delivery of the assigned clinical research projects or tasks within his/her defined territory under the supervision of the Senior Clinical Operations Manager or equivalence. The SCRA should work independently and would be expected to be the functional expert on the CRA role and could coach junior level CRAs. Responsibilities of SCRA include performing clinical on-site monitoring activities (including selection, initiation, monitoring, closeout of investigational sites, etc), participating in the project management and taking the lead CRA role in assigned projects.

Major Duties:

Manage the assigned tasks or clinical projects in 100% compliance with ICH-GCP, relevant SOPs, Local Regulations, other applicable laws and guidelines, and within the agreed timeline, including but not limited to:

• Building relationships with investigators and site staff.
• Conducting study feasibility survey and site selection.
• Preparing required regulatory and IRB/IEC submissions.
• Providing training to study staff on conducting the project.
• Conducting local investigator meetings, study nurse/CRC training, and site Initiation.
• Performing monitoring visits according to the approved Monitoring Plan.
• Managing site Investigational Product (IP) supply management.
• Conducting source data/document verification (SDV) in compliance with the Monitoring Plan and data review timelines.
• Assisting and ensuring site staffs complete CRFs and answer data queries within the timeline defined in the Monitoring Plan.
• Completing monitoring visit reports and required follow-up actions.
• Ensuring compliance of pharmacovigilance and drug accountability.
• Being responsible for the completeness and quality of the on-site files.
• Identifying and resolving or escalating any issues to CTM in a timely manner.
• Closing out study sites on completion of the project, and ensuring no outstanding open issues.
• Maintaining and archiving study documentation and correspondence.
• Preparing and attending audit and inspection as needed.
• Acting as mentor and role model for other CRA team members to ensure study specific training for CRAs.
• Acting as a Lead CRA in assigned projects.
• Performing co-monitoring visits with junior CRAs or as required.
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Job Requirements

• Bachelor degree or above, majoring in medical, pharmaceutical or other
  bio-science related area.
• 3 years’ experience as CRA, phase 1 trial experience highly preferred
• Excellent written and oral skills in English
• Excellent communication and presentation skills.
• Good working knowledge of relevant software such as MS-office (Excel, Word and
  PowerPoint, etc).
• Strong attention to details.
• Ability to successfully work in a team environment.
• Sound problem solving skills.
• Ability to prioritize multiple tasks and achieve project timelines.
• Able to take initiative and work independently.
• Effective time management in order to meet daily metrics or team objectives.
• Demonstrated superior monitoring skills and sound independent professional
  judgment.

瑞石生物医药有限公司于2018年1月创立，总部位于中国上海，在北京及美国波士顿设有分支机构，是一家创新的研发驱动型全球生物制药公司，立足于开发临床急需的创新药物以满足患者的需求。目前，瑞石专注于自身免疫类疾病创新药物的全球开发，一方面与国内领先的制药企业恒瑞合作将中国创新药物引入美国及欧洲，助力中国创新走向世界；另一方面还借助公司管理团队在中国开展创新药物研发的丰富经验，积极引进国际领先的创新药物解决中国患者的临床需求。