高级临床研究专员 - 肿瘤科
Sr Clinical Research Associate - Oncology
作为制药支持行业的领军企业，UBC致力于为更美好的明天赋能健康解决方案。我们以改善患者结果和推动医疗进步为荣。在UBC，我们提供服务以提升整个药物研发过程和商业化生命周期——从临床试验支持到真实世界证据的生成。
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我们正在寻找一位位于美国的高级临床研究助理（Sr. CRA），具有5年监查经验，其中至少3年在肿瘤学领域，以及一些眼科监查经验。
职位名称：YLM02H - 高级临床研究助理（SCRA）
简要描述：监查临床试验和观察性研究，确保遵循方案，管理站点活动，并监督数据收集和完整性。确保站点按照适用法规和指南以及申办方要求开展研究和报告研究数据。指导和培训初级临床研究助理。
具体工作职责：
- 熟悉并应用项目特定的方案
- 按照项目特定的时间表进行远程和现场监查
- 按照项目特定和UBC的差旅政策安排差旅日程
- 按照UBC的要求提交费用报销单
- 参加项目团队会议、部门会议以及与经理的一对一会议
- 按照UBC和/或申办方的标准操作规程完成站点监查报告和信函，需要最少的修改
- 按照UBC/申办方的时间表跟进站点问题和行动项
- 将站点访问、站点监查报告、已发送跟进信件的日期和站点联系人录入UBC的临床试验管理系统（CTMS）
- 监督电子数据采集（EDC）的数据录入，如适用，并协助站点解决电子病例报告表（eCRF）的问题
- 审核研究者站点文件并执行研究用药的清点
- 按照研究要求与指定站点保持定期联系
- 在规定时间内完成所有SOP审查、培训评估和文档工作
- 协助项目经理（PM）和管理团队
查看英文原文
As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.
Embark on a rewardingcareer journey with UBC! Growyour career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in aninclusive workplacethat fosters creativity.
If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC!
We are seeking a US-based Sr. CRA with 5 years of monitoring experience, including at least 3 years in oncology and some ophthalmology monitoring.
Job Title:YLM02H - Senior Clinical Research Associate (SCRA)
Brief Description: Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. Mentors and trains junior level CRAs.
Specific job duties:
- Thorough knowledge and application of project specific protocol
- Performs remote and on-site monitoring in accordance with project specific timelines
- Completes travel scheduling in accordance with project specific and UBC travel policy
- Submits expense reports within UBC requirements
- Attends project team meetings, department meetings and one-to-one meetings with the manager
- Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections
- Ensures follow-up of site issues and action items per UBC/sponsor timelines
- Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into UBC’s Clinical Trial Management System (CTMS)
- Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution
- Reviews Investigator Site File and performs Investigational Product reconciliation
- Maintains regular contact with assigned sites per study requirements
- Completes all SOP review, training assessments and documentation within requested timelines
- Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs
- Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training
- Assists PM and/or Lead CRA with additional tasks as needed
- Travel up to 80% required in the North American region
- Completes Site Management and Monitoring activities in accordance with project specific plans and timelines
- Assists with other duties as assigned, which may align with other departments at UBC
Supervisory Responsibility:None
Desired Skills and Qualifications:
- Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience
- Minimum of 36 months on-site monitoring experience including site selection, initiation, management, and monitoring activities
- Comprehensive knowledge of medical terminology and regulatory guidelines
- Excellent critical thinking and resolution skills
- Excellent written and verbal communication skills in English and local language (as applicable)
- Experience working in clinical trials and observational studies preferred
- Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications
- Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment
Benefits:
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
Here are some of the exciting perks UBC offers:
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
Originally posted on Himalayas