出海雷达

Clinical Research Associate (Home-based, Adelaide)

其他限定地区(需当地身份)
公司medpace
薪资未公开
工作地点Australia
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
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 Australia 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。
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。

梅达佩斯可以为你提供什么?·灵活的工作条件 自家工作的机会和灵活的工作时间 · 澳大利亚已驻扎的合格候选人签证赞助及转让 · 竞争力交通补贴 · 年度奖励增加 · 可变薪酬奖金计划 利奖金直接根据你访问数量计算 · MEDPACE CRA TRAINING PROGRAM (PACE®) 无需研究经验,因为梅达佩丝提供了全面的初步和持续培训,与其他 CROs 无可比。通过我们的 PACE®培训方案,你将加入其他获得 CRA 卓越的专业人士:• PACE®提供了平台,以有效和自信地履行你的职责,增强你目前的能力,最终帮助你成为一个高功能独立的 Medpace CRA. • PACE ®将通过互动讨论和与工作相关的练习和实践来培养你的 CRA 技能,为你做好准备。•为了补充你内部和现场培训,你还可以参加其他临床研究部门核心轮换,学习药物/设备开发和批准过程的其他方面。·每月不需要最低数量的日位在现场进行测量。· 机会担任跨职业和 CRA 领导职位 CRA 负责人,CRA 经理,临床试验管理人员·航空公司俱乐部补贴•随机服装代码责任•按照批准协议进行研究地点的资格化,启动,监测和闭包访问;·与医疗场地工作人员,包括协调员,临床研究医生及其现场工作人员沟通;·检查适当的调查员资格,培训和资源,包括设施,实验室,设备和人员;· 检查医疗记录和研究来源文件与案例报告表格数据进行验证,包括通知现场工作人员任何输入错误,确保遵守良好的文档实践并适当地传达根据 SOP,GCP 和适用的监管要求的协议偏差;· 确认调查员仅招募合格受试者;· 审查监管文件;· 研究产品/药物问责制和库存;· 检测和审查不良事件,严重不良事件以及随之而来的药物及相关疾病以确认按照议定书准确的报告;·评估临床研究。

查看英文原文

What can Medpace offer you?

  • Flexible working conditions – Opportunity to work from home and flexible working hours
  • Visa sponsorship & transfer for qualified candidates already based in Australia
  • Competitive transportation allowance
  • Annual Merit increases
  • Variable Compensation Bonus Plan – Lucrative bonus calculated directly from the number of visits you do
  • MEDPACE CRA TRAINING PROGRAM (PACE®)
  • No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE® Training Program, you will join other Professionals Achieving CRA Excellence:

• PACE®provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
• PACE®will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums.
• To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.

  • No metric for minimum required days on site per month.
  • Opportunity for cross-functional and CRA leadership positions – Lead CRA, CRA Manager, Clinical Trial Manager
  • Airline club allowance
  • Casual Dress Code

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;
  • 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

  • Bachelor's degree in a health or science related field;
  • Prior 2 years of study coordinator/clinical research coordinator experience is preferred; and
  • Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.

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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