出海雷达

临床研究协调员负责人

Lead Clinical Research Coordinator

其他限定地区(需当地身份)
公司Lifelancer
薪资$49,200 - $123,000/年
工作地点United States
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13 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 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。

职位名称:首席临床研究协调员
工作地点:美国哥伦比亚特区华盛顿
工作地点类型:远程
工作合同类型:全职
职位级别:

MCRA 是 IQVIA MedTech 的一部分。作为值得信赖的 CRO 和咨询合作伙伴,IQVIA MedTech 和 MCRA 为医疗设备和诊断行业提供整合的生命周期解决方案。我们共同支持从概念到商业化的创新,提供在监管策略、临床试验设计与执行、市场准入以及上市后优化方面的专业知识。我们的团队结合深厚的治疗领域知识与先进的数据和技术,帮助客户做出更明智的决策并在市场中蓬勃发展。加入我们的团队,共同塑造医疗科技的未来。

简介

首席临床研究协调员在支持临床研究项目的执行中发挥关键作用,通过协调并执行符合研究方案、标准操作规程(SOP)和良好临床实践(GCP)的远程临床活动。该职位负责执行多种临床程序,以收集、记录、报告和解读参与或寻求参与临床研究的患者数据。

职责与义务

  • 在进行所有与研究相关的活动时遵守 SOP 和操作手册,以确保合规性和一致性。这包括掌握与研究相关的软件应用和设备。
  • 与研究团队和研究站点合作,识别、招募并虚拟入组符合条件的临床试验患者。
  • 按照法规和组织标准收集、维护并安全存储与临床研究试验相关的所有数据。
  • 向潜在参与者介绍临床研究试验,包括研究要求,并通过虚拟互动管理知情同意流程。
  • 协助研究参与者遵守研究协议,提供指导和提醒以确保遵循协议要求。
  • 进行临床试验的随访活动,同时遵守良好临床实践(GCP)指南。
  • 通过监测参与者、及时报告不良事件并确保遵循 IRB 批准的方案来保障患者安全。
  • 根据安排支持研究参与者呼叫中心,处理咨询并提供协助。
  • 保持专业性
查看英文原文

Job Title: Lead Clinical Research Coordinator
Job Location: Washington, District Of Columbia, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.
Overview

The Lead Clinical Research Coordinator plays a critical role in supporting the execution of clinical research studies by coordinating and performing remote clinical activities in compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP). This role is responsible for performing a variety of clinical procedures to collect, record, report, and interpret patient data for individuals enrolled in or seeking enrollment in clinical studies.

Responsibilities and Duties

  • Adhere to SOPs and Manual of Procedures when conducting all study-related activities to ensure compliance and consistency. This includes maintaining a working knowledge of study-specific software applications and equipment.
  • Collaborate with the research team and study sites to identify, recruit, and virtually enroll eligible patients for clinical trials.
  • Collect, maintain, and securely store all relevant data associated with clinical research trials in accordance with regulatory and organizational standards.
  • Educate potential participants about clinical research trials, including study requirements, and manage the informed consent process through virtual interactions.
  • Assist with participant study compliance by providing guidance and reminders to ensure adherence to protocol requirements.
  • Conduct follow-up activities for clinical trials while maintaining adherence to Good Clinical Practice (GCP) guidelines.
  • Ensure patient safety by monitoring participants, reporting adverse events promptly, and ensuring compliance with IRB-approved protocols.
  • Support the research participant call center as assigned, handling inquiries and providing assistance.
  • Maintain professionalism in all interactions with research participants to foster trust and engagement.
  • Assist with study equipment management and reporting, ensuring proper tracking, functionality, and documentation.
  • Communicate effectively with MCRA clinical affairs staff and clients, providing updates and support under the guidance of senior MCRA staff as needed.
  • Perform additional duties and projects as assigned to support the success of clinical research operations.

Required Knowledge, Skills, and Experience

  • Education: Bachelor’s degree required (preferably in a life sciences or healthcare-related field)
  • Experience: Minimum of three years of experience as a Clinical Coordinator or in a comparable clinical research role
  • Strong attention to detail
  • Excellent verbal and written communication skills

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $49,200.00 - $123,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas

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