出海雷达

Experienced Clinical Research Associate (remote-based)

职能支持限定地区(需当地身份)日间重叠约 2 小时,需偶尔早起或晚睡
公司medpace
薪资未公开
工作地点Austria
地域资格限定地区(需当地身份)
时区要求日间重叠约 2 小时,需偶尔早起或晚睡
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 Austria 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。
作息提示:日间重叠约 2 小时,需偶尔早起或晚睡。
关于本页中文:职位描述由本机离线模型翻译,属机器翻译,供快速判断用;正式沟通与投递请以英文原文为准。官方翻译通道恢复后会自动重译升级。

我们的临床活动正在迅速发展,我们目前正在寻找一个经验丰富的临床研究员加入我们的奥地利临床运营团队 (本土).这个职位将在团队中完成对公司成功至关重要的任务和项目。如果你想要一种令人兴奋的职业生涯,在那里你可以利用以前的专业知识,并且能够进一步发展和增长你的职业生涯。这是你的机会!责任 · 按照批准协议进行资格,启动,监测和闭幕访问研究地点;·与医疗场所工作人员,包括协调员,临床研究医生和其现场工作人员的沟通;· 验证适当的调查员资格,培训和资源,包括设施,实验室,设备和人员;· 对病例报告表单数据进行医学记录和研究来源文件核查,包括向现场工作者告知任何输入错误,确保遵守良好文档实践并根据 SOP,GCP 和适用的监管要求适当地传达协议偏差;· 检查调查员仅招募合格主体;· 审查法规文件;· 检查和审查不良事件,严重的不良事件和随之而来的药物以及相关疾病以确认根据协议进行准确数据报告;·评估临床研究场所选患者并保留患者成功情况并提出改善建议;·完成监测报告和后续信件,包括提供重大发现,偏差,缺陷和确保合规措施的总结。资格 ·必须至少获得大学学位在健康或生命科学相关领域;· 最小的时间:经验1.5年,作为 CRA; · 德国,奥地利和瑞士旅行约60至80%; · 熟练了解 Microsoft® Office 及一般计算机素养;· 卓越的沟通和演示技能;· 必须以细节为导向和有效的方式管理时间;· 英语和德语语言的口头和书面交流能力;· 在临床患者管理,协议,CRF,ISF 编制,文件等方面具有证明经验。

查看英文原文

Our clinical activities are growing rapidly, and we are currently seeking an Experienced Clinical Research Associate to join our Clinical Operations team in Austria (home-based). This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!

Responsibilities

  • Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
  • Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
  • Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
  • Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
  • Verification that the investigator is enrolling only eligible subjects;
  • Regulatory document review;
  • Medical device and/or investigational product/drug accountability and inventory;
  • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  • Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

  • Must have a minimum of a university degree in a health or life science related field;
  • Min. 1.5 years of previous experience as a CRA;
  • Approximately 60-80% travel in Germany, Austria and Switzerland;
  • Proficient knowledge of Microsoft® Office and general computer literacy;
  • Outstanding communication and Presentation skills;
  • Must be detail-oriented and efficient in time management;
  • Excellent verbal and written communication skills in English and German;
  • Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.

Please note that this role is fully remote-based in Austria. We kindly ask you to submit your application in English.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
· · Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture
·
· Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.

  • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development
·
· Office based environment with on-site mentors

  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits
·
· Competitive compensation programs that recognize and reward performance

  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events

Please note benefits may vary based on country.

What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
Originally posted on Himalayas

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