临床研究助理
Clinical Research Associate
BeOne持续以快速的速度发展，为有经验的专业人士提供具有挑战性和令人兴奋的机会。在考虑候选人时，我们寻找具有高度积极性、协作精神，并且最重要的是，与我们一样对抗击癌症充满热情的科学和商业专业人士。
职位描述：
- CRA在临床试验现场执行临床监查活动，并根据ICH指南和GCP、当地法规及适用的SOP监控临床试验。
- 在指定区域内执行与选择、启动、实施（招募、高质量数据收集）以及及时完成肿瘤学/血液学临床试验相关的监查活动。
- 与区域临床运营经理密切合作，确保研究时间表得到遵守，并保持所需的质量标准。
- 识别差距和改进领域，并提出CAPA。
- 支持启动工作并提供本地专业知识。
- 具有SSU经验者优先
CRA职责：
- 执行可行性评估、机构识别、选择和评估，支持初始机构名单和招募目标。
- 向指定机构提供方案及相关研究培训。
- 按照监查计划和适用的SOP进行监查（预研究、启动、常规监查和结题访问）。
- 如需要，进行联合监查访问。
- 根据ICH-GCP、BeOne Medicines标准和SOP完成监查访问报告。
- 通过跟踪监管提交、招募、病例报告表（CRF）完成情况和数据查询解决情况来管理机构和机构表现。
- 与机构建立定期沟通渠道，并向临床运营报告机构进展、问题和建议的行动方案。
- 确保研究和机构的检查准备就绪。
- 与区域临床运营经理和临床研究机构合作，确保研究里程碑（如研究启动、招募、数据库分析、结题等）按时交付。
- 按要求参加疾病适应症项目特定培训和一般CRA培训。
- 如需要，协助开展研究监督访问（SOVs）、机构审计和/或检查。
- 评估机构实践的质量和完整性——根据需要向研究者和内部团队升级质量和/或GCP问题。
- 预见并识别机构问题；提出纠正和预防措施；识别
查看英文原文
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
- The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
- Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
- The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
- Identify gaps and areas for improvement and propose CAPA.
- Supports start-up and provides local expertise.
- SSU experience is considered a plus
CRA activities
- Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
- Provides protocol and related study training to assigned sites.
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs
- Conducts co-monitoring visits, if required
- Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP
- Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
- Ensure inspection readiness of the study and sites
- Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends disease indication project specific training and general CRA training as required
- Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
- Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
- Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Education Required:
- BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
- Experience in oncology global trials preferred
Other Qualifications:
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English & Turkish (writing and speaking)
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel: up to 60%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Originally posted on Himalayas