南京招聘

职位描述：
General Summary
The In House Clinical Research Associate I (IHCRA I) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
Key Responsibilities:
 Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
 Utilizes the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.
 Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
 Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
 Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
 Documents site and Sponsor contact and study interactions in a timely and professional manner.
 Assists with resolution of investigational site/data queries. Liaises with project team members regarding study site issues. Provides quality review of the informed consent template.
 Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
 Follows up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments.
 Performs other duties as assigned.
 Liaises with internal and external customers to meet project specific goals including participation in sponsor and project related meetings
 Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals
 Identifies, monitors, documents, and tracks out-of-scope activities.
Supports Clinical Team Manager (CTM)/Country Start-Up Specialist (CSS) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
 Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query
 Distribution to/from investigational sites.
 Proficient in the development and review of Informed Consent Form templates.
 May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents. Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the CSS/CTM.
 Supports the CTM/CSS/CRA to resolve internal and external clinical issues for client research projects managed by PRA.
 Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions.
 Supports CTM/CSS/CRA in the management of clinical budget and evaluation of study processes.
 Evaluates metric data to identify process improvements. Assists with managing and training staff.
Manages time and project requirements based on study contract.

Job Factors (Knowledge, Skills and Abilities)
          Knowledge & Skills
 Demonstrates good working knowledge of PRA systems and work environment
 Demonstrates thorough knowledge of clinical research industry standards, practices, and regulations
 Exhibits good decision making skills utilizing all available resources for determining positive outcomes.
 Successfully interacts with both internal and external customers, representing the organization on specific projects.

       Problem solving Fact Finding & Analysis
 Develops solutions to a variety of moderate to complex issues independently.
 Refers to established policies and practices for guidance.

Impact
 
 Contributes to the completion of organizational projects and goals.
 Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.

Supervision Given/Received
 Works under only very general supervision. Work is reviewed throughout the process for soundness of judgment, accuracy, and adequacy.
 May be in a leadership/ mentoring role for a specific project.

Qualifications
             Education
 Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional

             Experience
 0 – 2 years of related experience prior experience using computerized information systems.
 Read, write, and speak fluent English; fluent in host country language required
 Minimum of 2 years of related experience
 Experience with PC-Windows, word processing, and electronic spreadsheets required.
 Knowledge of ICH and local regulatory authority drug research and development regulations required.
 Clinical trials support or pharmaceutical industry experience required.
             Preferred Education and/or Experience
            Experience leading a team in a clinical research environment preferred. 举报 分享

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。