IQVIA

Runs drug trials and sells health data to pharma

Clinical Research Associate 1/2/Senior - Device

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeNo salary listedIn-person

About the Job

Requirements

Conduct study-site selection, initiation, monitoring, and close-out visits in accordance with study protocols, contractual scope of work, standard operating procedures, and Good Clinical Practice requirements.
May manage site monitoring responsibilities across multiple protocols, sites, and therapeutic areas.

Responsibilities

Provide protocol- and study-related training to assigned sites and communicate with them regularly to manage ongoing project requirements and issues.
Assess the quality and integrity of site work and determine whether studies are conducted according to the protocol and applicable regulations; report quality issues to the responsible project manager and/or line manager.
Manage assigned site progress by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and generation and resolution of data queries.
Create and maintain documents related to site management, monitoring visit findings, and action plans; submit visit reports and other required study documents.
Manage study finances for assigned sites.
Collaborate with other functional departments.
Complete other work assigned by the line manager and/or project manager.

根据试验方案、合同规定的工作范围、SOP和GCP的要求进行研究中心筛选、启动、监查和关闭访视。
可同时负责多个方案、研究中心和治疗领域内的研究中心监查工作。
对所负责的研究中心进行方案和研究相关的培训，与研究中心进行定期沟通以管理项目进行中的要求和问题。
评估研究中心工作的质量和完整性，确定研究中心是否是按照方案和适用的法规进行研究。将质量问题汇报给负责的PM和/或直线经理。
通过追踪注册申报和批复、招募和入选、病例报告表（CRF）完成和递交、以及数据疑问产生和解决的情况，管理所负责研究中心的进展。
创建和维护与研究中心管理、监查访视的发现以及行动计划相关的文件，递交访视报告和其他所需研究文件。
负责相应研究中心的研究财务管理。
与其他职能部门共同合作。
完成直线经理和/或项目经理（PM）分配的其他工作。

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 https://jobs.iqvia.com

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.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size: 10,001+
Company stage: IPO
Headquarters: Durham, NC
Founded: 1998

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