出海雷达

Experienced Clinical Research Associate

其他未标注地域日间重叠约 2 小时,需偶尔早起或晚睡
公司medpace
薪资未公开
工作地点Croatia
地域资格未标注地域
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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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。

我们的欧洲临床活动正在迅速发展,我们目前在寻找全职家庭临床研究员加入我们的临床监测团队。这是一个新的,永久性的实体,我们很高兴能够增长这个拥有惊人的当地人才的团队。这一职位将有助于使该团队在克罗地亚成长并完成对公司成功至关重要的任务和项目。如果你想要使用以前的专业知识,并且可以进一步发展和扩大你的职业生涯的令人兴奋的职业生涯,那么这就是你自己的机会。医疗保健研究员在医学治疗的发展阶段都有机会参与不同领域,包括罕见疾病,细胞和基因治疗。我们的成功临床研究员在医疗和相关卫生保健领域拥有多种背景,包括但不限于;注册护士,饮食师,药剂师,科学系毕业生和研究助理。广泛的培训计划提供了平台以有效地和自信地履行你的职责,Medpace 独特的方式。· 根据批准协议进行研究地点的资格,启动,监测和结局访问;· 与医疗场所工作人员沟通,包括协调员,临床研究医生及其现场工作人员;· 验证适当的调查人员资格,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,确保遵守良好的文档实践并按 SOP,GCP 和适用的法规要求妥善传达议定书偏差;· 验证调查人员仅招募符合条件的受试者;· 监管文件审查;· 医疗器械和/或研究产品/药物责任与库存;· 检查并审查不良事件,严重不良事件和随之而来的药物以及相应疾病以确认根据协议准确的数据报告;·评估临床研究场所选和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:

查看英文原文

Our European clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Monitoring team, in the country of Croatia. This is a new, permanent, entity for us and we are excited to grow this team with amazing local talent.
This position will be instrumental in growing the team in Croatia and accomplishing tasks and projects that are vital 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.
The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the development of medical therapeutics, in different, including rare diseases, cell and gene therapy, areas. Our successful Clinical Research Associates possess varied backgrounds in the medical and related healthcare fields, including but not limited to; Registered Nurses, Dieticians, Pharmacists, Faculty of Science Graduates and Research Assistants. An extensive training program provides the platform to effectively and confidently carry out your duties, the Medpace unique way.

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

  • Minimum a Bachelor of science in health-related field, MD or equivalent
  • Minimum of 1 year independent CRA monitoring
  • Broad knowledge of medical terminology and clinical patient management
  • Basic knowledge of drug therapy techniques and clinical research methodologies
  • Comprehensive knowledge of Local Regulations and ICH GCP
  • Excellent oral and written communication skills
  • Fluency in Croatian and English
  • Great attention to detail
  • Must hold a valid driver’s license
  • We kindly ask to submit applications 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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