站点激活协调员
Site Activation Coordinator
职位名称：站点激活协调员
工作地点：北卡罗来纳州达勒姆，美国
工作地点类型：远程
工作合同类型：全职
职位级别：
职位概述
在一般监督下，根据适用的当地和/或国际法规、标准操作规程（SOP）、项目要求和合同/预算指南，在国家层面执行与站点激活活动相关的任务。可能还包括维护活动。
主要职责
- 在一般监督下，根据适用的法规、SOP 和工作指令，为指定研究的调查站点执行站点激活活动，与站点激活经理（SAM）、项目管理团队及其他必要部门密切合作。在高级员工的指导下，审查文件的完整性、一致性和准确性。
- • 准备站点监管文件，并审查其完整性和准确性。
- • 通知团队成员各站点监管和合同文件的完成情况。
- • 将完成的文件分发给站点和内部项目团队成员。
- • 支持内部系统、数据库、跟踪工具、时间线和项目计划的更新和维护，提供准确且完整的项目特定信息。
- • 审查、跟踪并跟进文件的进度、批准和执行情况，包括监管、伦理、知情同意书（ICF）和研究者手册（IP）发布文件。
资格要求
- 生命科学或相关领域的学士学位。
- • 在医疗保健环境中有 1 年经验，或教育、培训和经验的等效组合。能够在一般监督下独立工作的高效个人。所面临的问题通常是常规性的，但可能需要解释程序或政策以解决。
- • 良好的人际沟通和组织能力。
- • 良好的文字处理技能，熟悉 MS Office 应用程序。
• 对临床试验环境和药物开发流程有基本了解。
• 能够同时处理多个项目。
• 能够与同事、经理和赞助商建立并维持有效的合作关系。
IQVIA 是生命科学和医疗行业领先的临床研究服务、商业洞察和医疗智能提供商。我们通过创造智能连接，加速药物的研发和商业化进程。
查看英文原文
Job Title: Site Activation Coordinator
Job Location: Durham, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Overview
Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions
- Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
- • Prepare site regulatory documents, reviewing for completeness and accuracy.
- • Inform team members of completion of regulatory and contractual documents for individual sites.
- • Distribute completed documents to sites and internal project team members.
- • Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Qualifications
- Bachelor's Degree Life sciences or a related field . Pref
- • 1 years’ experience in a healthcare environment or equivalent combination of education, training and experience. Productive individual contributor who works under general supervision. Problems faced are generally routine but may require interpreting proceedures or policies to resolve.
- • Good interpersonal communication and organizational skills.
- • Good word processing skills and knowledge of MS Office applications.
• Good attention to detail.
- General awareness clinical trial environment and drug development process.
- • Ability to work on multiple projects.
- • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
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 $35,800.00 - $102,000.00. 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.
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Originally posted on Himalayas