FSP 法规与启动专员 2
FSP Regulatory & Start Up Specialist 2
职位名称：FSP 监管与启动专家 2
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
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，执行与站点激活（SA）活动相关的国家层面任务。可能还包括维护活动。
主要职责
- 在一般监督下，作为指定研究中的研究站点、站点激活经理（SAM）、项目管理团队和其他部门的单一联系人（SPOC）。确保遵守标准操作规程（SOP）、工作说明（WIs）、指定交付物的质量和项目时间表。
- • 根据适用的法规、SOP 和工作说明执行启动和站点激活活动。将完成的文件分发给站点和内部项目团队成员。
- • 准备站点监管文件，并审查其完整性和准确性。
- • 确保内部系统、数据库和跟踪工具准确填写项目相关信息。
- • 审核并就站点绩效指标向管理层提供反馈。
- • 审核、制定并达成项目计划和项目时间表。确保监控措施到位，并在需要时实施应急计划。
- • 通知团队成员各站点监管和合同文件的完成情况。
- • 审核、跟踪并跟进文件的进度、审批和执行情况，包括监管、伦理、知情同意书（ICF）和研究者手册（IP）发布文件，符合项目时间表。
- • 在初始和持续的项目时间表规划期间，为 SAM 和项目团队提供本地专业知识。
- • 对站点提供的文件进行质量控制。
- • 可能直接与发起方就特定项目进行沟通。
资格要求
- 生命科学或相关领域的学士学位，3 年临床研究或其他相关经验；或教育、培训和经验的等效组合。
- • 3 年临床研究经验，包括 1 年领导岗位经验。教育、培训和经验的等效组合。
- • 深入了解临床系统、程序和公司标准。
- • 良好的谈判和沟通技能
查看英文原文
Job Title: FSP Regulatory & Start Up Specialist 2
Job Location: Durham, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Overview
Perform tasks at a country level associated with Site Activation (SA) 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, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- • Prepare site regulatory documents, reviewing for completeness and accuracy.
- • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- • Review and provide feedback to management on site performance metrics.
- • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- • Inform team members of completion of regulatory and contractual documents for individual sites.
- • 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, in line with project timelines.
- • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- • Perform quality control of documents provided by sites.
- • May have direct contact with sponsors on specific initiatives.
Qualifications
- Bachelor's Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- • 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
- • In-depth knowledge of clinical systems, procedures, and corporate standards.
- • Good negotiating and communication skills with ability to challenge, if applicable.
- • Effective communication, organizational, and interpersonal skills.
- • Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- • Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
- • Understanding of regulated clinical trial environment and knowledge of drug development process.
- • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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 $60,300.00 - $157,100.00. 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