临床研究助理（CRA）-心血管医疗器械
Clinical Research Associate (CRA) -Cardiovascular Medical Device
市场运营限定地区（需当地身份）
公司MiRus
薪资未公开
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18 天前
数据来源Himalayas
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：临床研究助理（CRA）- 心血管医疗器械
地点：远程办公
职位概述：
协助管理 MiRus 产品的心血管临床研究，重点关注关键时间线的遵守、高质量文档的开发和数据收集。申请人应具备良好的批判性思维能力，能够理解技术主题内容，以有效为组织做出贡献。
主要职责和任务：
- 参与研究方案、修正案、知情同意书、委员会章程、研究报告、监查计划及其他相关临床和监管文件的内容生成、撰写和编辑。
- 协助管理从开始到结束的试验研究。
- 与跨职能团队合作，包括临床和非临床研究与开发小组，参与新试验设计。
- 参与病例报告表（CRF）的开发。
- 协助制定培训材料并为研究人员、研究协调员及相关研究现场人员提供临床试验实施的培训。
- 协助研究经理进行安全监查，包括准备 CEC 和/或 DSMB 的支持文件、会议、议程、数据审查、演示文稿，并根据需要更新相关跟踪表。
- 作为临床现场研究人员与 MiRus 团队之间的联系人。
- 与研究人员和现场人员合作，快速有效地解决差异问题。
- 可能负责患者入组及跟踪临床研究项目的站点付款。
- 作为 CRO 人员与 MiRus 之间的联系人。
- 监督/支持 CRO 和现场研究监查员，处理监查相关事项并跟进研究任务。
- 监督研究方案的持续合规性，符合适用法规和 GCP、工作说明、指南和/或政策。
- 对原始文件、病例报告表、数据报告等进行持续的数据审查。
- 协助审核监查报告并跟踪行动项。
- 审核原始文件以确认受试者是否符合临床试验资格。
- 跟踪并上传研究影像资料。
- 管理临床研究文档（试验主文件和相关跟踪文件）。
- 根据需要更新和设计研究仪表板、研究跟踪表和其他相关研究文件，以提供定期更新。
查看英文原文
Role: Clinical Research Associate (CRA) - Cardiovascular Medical Device
Location: Remote
Position Summary:
Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.
Essential Duties and Responsibilities:
- Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
- Assist with the management of investigational studies from start through study closure.
- Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
- Contribute to the development of CRFs
- Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable.
- Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
- Serve as a point of contact between clinical site investigators and the MiRus team.
- Work with investigators and site personnel to quickly and effectively resolve discrepancies.
- May be responsible for patient accruals and tracking payments to sites for clinical study programs
- Serve as a point of contact between CRO personnel and MiRus.
- Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
- Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
- Provide continuous data review of source documents, case report forms, data reports as appropriate.
- Assist in review of monitoring reports and tracking of action items.
- Review source documentation to confirm subject eligibility for clinical trials.
- Track and upload study imaging
- Manage clinical study documentation (trial master file and study related tracking).
- Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager
- Interact with data management, as applicable
- Support applications and technical files as needed.
- Assist with preparation for investigators meetings.
Minimum Education and/or Experience:
- Bachelor’s or Master’s degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role. CRA certification desired.
- At least 2 years of experience in clinical research role, with at least 2 years in CRA role, preferably in cardiovascular medical device.
- Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
- Current knowledge of medical device clinical trials design and best practices.
- Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
- General application of medical terminology (cardiovascular specific preferred).
Benefits:MiRus offers competitive compensation, options, full benefits, and relocation assistance.
- 401(k)
- Dental insurance
- Vision insurance
- Disability insurance
- Employee assistance program
- Flexible spending account or Health Savings Account
- Health insurance
- Life insurance
- Paid time off
Schedule:
- Monday to Friday (8am – 5pm)
Work Location:
- Remote
- Position may require domestic travel at least 20-40%
Originally posted on Himalayas
本页面信息整理自 Himalayas，版权归原发布方所有。职位可能随时关闭，投递请以原始页面为准。
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