临床研究协调员 II，I 期 - 德克萨斯州/中西部
Clinical Research Associate II, Phase I - Texas/Mid-West
职位名称：临床研究助理 II，I 期 - 德克萨斯/中西部
工作地点：远程，堪萨斯州
工作地点类型：远程
工作合同类型：全职
职位级别：
我们的 I 期团队正在寻找具有 1 年以上经验的临床研究助理。理想的候选人应具有 I 期经验，并居住在德克萨斯州或中西部（堪萨斯州、密苏里州、内布拉斯加州、爱荷华州、科罗拉多州）。
你将负责
你将利用你的技能、知识和临床判断，为临床试验参与者提供高标准的护理，并根据临床研究标准应对紧急情况。
职责：
- 负责研究现场监控的所有方面，包括常规监控和现场关闭，研究文件的维护，预研究和启动访问的进行；与供应商联络；以及其他指定的任务 -
- 负责项目计划中规定的所有现场管理方面
- 一般现场监控
- 确保将按照方案开展试验的研究人员已获得适当的材料和指导，以安全地将患者纳入试验
- 通过验证知情同意程序和方案要求是否符合适用的监管要求，确保研究患者的保护
- 通过仔细的源文件监控，确保提交的病例报告表（CRFs）或其他数据收集工具中的数据完整性，监控缺失或不合理数据
- 负责项目计划中规定的注册管理的所有方面 - 在需要时进行可行性工作
- 完成严重不良事件（SAE）报告，生成报告、叙述和 SAEs 的后续处理
- 独立执行 CRF 审核；根据 Fortrea 或客户数据管理系统中设定的数据审核指南生成和解决查询，按管理层指派进行
- 协助新员工的培训，例如共同监控
- 作为本地项目协调员（如适用，有监督）协调指定的临床项目，并可能根据指派担任本地客户联系人
- 执行管理层指派的其他任务
要求
- 大学或学院学位，或来自适当认证机构的相关辅助健康专业认证（例如护理执照）
- 1 年以上临床监控经验
- 具有 I 期经验
- 40-50% 的过夜出差
查看英文原文
Job Title: Clinical Research Associate II, Phase I - Texas/Mid-West
Job Location: Remote Kansas
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Our Phase I team is currently seeking a Clinical Research Associate with 1+ years of experience. Ideal candidates would have phase I experience and reside in Texas or Mid-West (Kansas, Missouri, Nebraska, Iowa, Colorado).
WHAT YOU WILL DO
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities:
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
- Responsible for all aspects of site management as prescribed in the project plans
- General On-Site Monitoring
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
- Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
- Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
- Assist with training of new employees, eg. co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
- Perform other duties as assigned by management
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 1+ years of Clinical Monitoring experience
- Phase I experience
- 40-50% overnight travel
The important thing for us is you are comfortable working in an environment that is:
- Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
- Changing priorities constantly asking you to prioritize and adapt on the spot.
- Teamwork and people skills are essential for the study to run smoothly.
- Technology based. We collect our data directly into an electronic environment.
Work Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequent travel to clients/ site locations with occasional travel both domestic and international.
Physical Requirements:
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
- Target Pay Range: $100 - $120K
#LI - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here.
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Originally posted on Himalayas