上海招聘

PURPOSE

Under general supervision, perform activities associated with study site initiation process according to applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

May participate in feasibility and/or site identification activities.

RESPONSIBILITIES

Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:

·？Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.

·？Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.

·？Review and provide feedback to management on site performance metrics.

·？Serve as contact for investigative sites, designated project reports, communications, and customer service.

·？Resolve site issues and determine status for product shipment.

·？Work with regulatory team members or sponsor to secure authorization of regulatory documents.

·？Work with legal team members or sponsor to secure authorization of contracts.

·？Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.

·？Inform team members of completion of regulatory and contractual documents for individual sites.

·？Work with team members in preparation of regulatory submissions per work instructions.

·？May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.

·？May translate or review completed translations of critical documents.

·？May participate in feasibility and/or site identification activities.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

·？In-depth knowledge of clinical systems, procedures, and corporate standards

·？Strong knowledge of medical terminology and regulations

·？Broad knowledge of clinical research

·？Strong knowledge of Microsoft Office and e-mail applications

·？Effective communication, organizational, and interpersonal skills

·？Ability to work independently and to effectively prioritize tasks

·？Ability to manage multiple projects

·？Attention to detail

·？Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

·？Bachelor’s Degree in a related field and 1 year clinical research experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

·？Extensive use of telephone and face-to-face communication requiring accurate perception of speech

·？Extensive use of keyboard requiring repetitive motion of fingers

·？Regular sitting for extended periods of time

IQVIA（纽交所代码：IQV）是全球专注生命科学领域的高阶分析、技术解决方案和临床研究服务供应商。IQVIA利用深入分析、前沿技术、大数据资源和广泛领域的专业知识，智能连接医疗生态的各个环节。IQVIA Connected Intelligence？快速敏锐地为客户提供强大的数据洞察，帮助客户加速创新医疗的临床开发和商业化进程，以更好的医疗成果惠及患者。IQVIA拥有约72,000名员工，足迹遍布100多个国家/地区。

IQVIA拥有多元化的加强型隐私技术和保障手段，能够在保护个人隐私的同时对信息进行管理和分析，帮助医疗利益相关方有效开展精准疗法，获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方，获得对疾病、人类行为和科技进步更深入的理解，共同朝着治愈各类疾病的方向迈进。