长沙招聘

General Summary The Senior Clinical Research Associate I (Sr. CRA I) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Key responsibilities

• Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines

• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

• Provides regular site status information to team members, trial management, and updates trial management tool.

• Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations

• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

• Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed

• Performs essential document site file reconciliation

• Performs source document verification and query resolution

• Assesses IP accountability, dispensation, and compliance at the investigative sites

• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines

• Communicates with investigative sites

• Updates applicable tracking systems

• Ensures all required training is completed and documented

• Be assigned logistical support tasks by CTM for Investigator Meetings

• Implements and monitors local/global clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines

• Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial. Facilitates audit s and audit resolution

• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

• Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.as directed by study management

• Perform additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc.) ensuring relevant training completed ahead of conducting additional or extended tasks

• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines

• Serves as observation visit leader of CRA level 1 and 2

• May be assigned clinical tasks where advanced negotiating skills are required

• May be assigned training responsibilities with regards to coaching junior CRAs or supporting CTM at Investigator Meetings

Job Factors (Knowledge, Skills and Abilities) Knowledge & Skills ? Applies knowledge of Company s policies and procedures ? Demonstrates excellent written and oral communication ? Demonstrates excellent knowledge of ICH/GCP and relevant local requirements ? Displays ability to manage investigative sites to facilitate trial deliverables ? Demonstrates ability to escalate issues appropriately ? Conducts monitoring to confirm subject safety and data integrity ? Describes and demonstrates the principals of IP accountability9. Demonstrates working knowledge of Microsoft Office applications ? Demonstrates excellent knowledge of ICH GCP

? Identifies scientific misconduct at the site level

? Demonstrates working knowledge of Clinical Trial Management Systems, e-TMF, IVRS/IWRS and Electronic Data Capture Platforms ? Mentors CRAs new to the position or company ? Serves as an observation visit leader ? Identifies scientific misconduct at the site level and capability to manage effectively ? Reads, writes and speaks fluent English and is fluent in host country language Problem solving Fact Finding & Analysis

? Confirms investigative sites are appropriately utilizing protocol and trial process for trial conduct

? Confirms investigative sites are following ICH/GCP

? Resolves investigative site issues related to trial. Likely to involve seeking assistance from peers, quality assurance, team lead, project management, subject matter experts and functional management to resolve more complex and difficult issues.

? Demonstrates trial system compliance and skills

? Resolves investigative site issues related to trial with assistance from peers, quality assurance, team lead, project management, subject matter experts and functional management

? Utilizes Company systems to analysis investigative site metrics (i.e. backlog, enrollment, protocol deviations, and audits.) to appropriately manage the site

? Identifies new employee mentoring needs to provide acclimation to Company

? Resolves investigative site issues related to trial with very limited assistance from others.

? Has the capacity to resolve more complex and difficult issues with limited assistance

Impact

? Failure to adequately monitor and manage the investigative site could result is endangerment of subjects, safety, non-evaluable data, and failure to meet trial timelines.

Supervision Given/Received

? Requires Limited or minimal supervision under the guidance of functional management and /or CTM

? Independently performs daily normal work.

? Provides guidance and mentorship to less experienced CRAs

Qualifications

Education

? Undergraduate degree or its international equivalent in clinical, science, or health‐related field from an accredited institution; a licensed health‐care professional (i.e., registered nurse); or equivalent work experience required

Experience

? 4 years of local trial experience and/or minimum of 2 year of global trial experience

? Knowledge of ICH and local regulatory authority regulations regarding drug

? Experienced in CTMS, Etmf, EDC IVRS/IWRS system

Preferred Education and/or Experience

? Clinical research experience

? Knowledge of ICH and local regulatory authority regulations regarding drug

? An advanced degree (e.g., M.S., M.B.A., PharmD, etc.)

? Experience in monitoring all trial components (PSSV to COV)

? Experience in coaching/mentoring other CRAs

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。