南京招聘

General SummaryThe Clinical Research Associate II (CRA II) will monitor the progressof clinical studies at investigative sites or remotely, and ensure clinicaltrials are conducted, recorded, and reported in accordance with the protocol,standard operating procedures (SOPs), ICH-GCP, and all applicable regulatoryrequirements.

Keyresponsibilities

 

?      Implementsand monitors local clinical trials to ensure sponsor and investigator obligationsare being met and are compliant with applicable local regulatory requirementsand ICH‐GCP guidelines

?      Assessesthe qualification of potential investigative sites, initiates clinical trialsat investigative sites, instructs site personnel on the proper conduct ofclinical trials, and close clinical trials at investigative sites

?      Reviewsand verifies accuracy of clinical trial data collected, either onsite orremotely

?      Providesregular site status information to team members, trial management, and updatestrial management tool.

?      Completesmonitoring activity documents as required by Company or Sponsor SOPs or othercontractual obligations

?      Worksclosely with other clinical team members to facilitate timely resolution oftrial and/or clinical issues

?      Escalatessite and trial related issues per Company SOPs, until identified issues areresolved or closed

?      Performsessential document site file reconciliation

?      Performssource document verification and query resolution

?      AssessesIP accountability, dispensation, and compliance at the investigative sites

?      VerifiesSerious Adverse Event (SAE) reporting according to trial specifications andrelevant local and ICH GCP guidelines

?      Communicateswith investigative sites

?      Updatesapplicable tracking systems

?      Ensuresall required training is completed and documented

?      Beassigned logistical support tasks by CTM for Investigator Meetings

?      Implements and monitors local/globalclinical trials to ensure sponsor and investigator obligations are being metand are compliant with applicable local regulatory requirements and ICH‐GCPguidelines

?      Manage the essential documents, as required by local regulations andICH GCP, before, during and after a clinical trial. Facilitatesaudit s and audit resolution

?      Assessesthe qualification of potential investigative sites, initiates clinical trialsat investigative sites, instructs site personnel on the proper conduct ofclinical trials, and close clinical trials at investigative sites

 

Job Factors (Knowledge, Skillsand Abilities)?    Applies knowledge of Company s policies andprocedures?    Demonstrates excellentwritten and oral communication?    Demonstrates excellent knowledge of ICH/GCPand relevant local requirements?    Displays ability to manage investigative sitesto facilitate trial deliverables?    Demonstrates ability toescalate issues appropriately?    Conducts monitoring to confirm subject safety and dataintegrity?    Describesand demonstrates the principals of IP accountability9. Demonstratesworking    knowledge of Microsoft Officeapplications?    Demonstrates excellent knowledge of ICH GCP

   ?     Identifies scientific misconduct at the site level

Demonstrates working knowledge ofClinical Trial Management Systems, e-TMF, IVRS/IWRS and Electronic Data CapturePlatforms Problem solving Fact Finding& Analysis

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

   ?     Confirmsinvestigative sitesare following ICH/GCP

   ?     Resolvesinvestigative site issues related to trial. Likely to involve seekingassistance from peers,quality assurance, teamlead, project management,subject matter experts and functional management to resolve more complex and difficult issues.

   ?     Demonstratestrial system compliance and skills

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

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

 Impact?   Failure to adequatelymonitor and manage the investigative site could result is endangerment ofsubjects, safety, none valuable data, and failure to meet projecttimelines   SupervisionGiven/Received

?     Supervisionunder the guidance of functional manager, CTM and /or tenured SCRAs.

       Sometimes instruction needed on routine work.

Qualifications

Undergraduatedegree 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

2 to 4 years oflocal trial experience; exposure to MNC and global trialsClinical research experienceKnowledge of ICH and local regulatory authority regulations regardingdrugAnadvanced degree (e.g., M.S.,M.B.A., PharmD, etc.)

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。