艾昆纬医药科技（上海）有限公司招聘

IQVIA 艾昆纬 CRA1/CRA2/SCRA
办公地点：所在城市办公室（北上广成都）/其他城市Homebase
职责：
根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作
根据临床试验标准确保临床数据相关文档的准确性、时效性、完整性等
熟悉临床试验操作基本阶段和操作流程，及时反馈相关信息给临床项目团队
要求：
本科及以上学历
医药相关专业
1年以上CRA工作起
良好的英语读写能力，可进行基本对话

IQVIA 艾昆纬 CRA1/CRA2/SCRA
办公地点：所在城市办公室（北上广成都）/其他城市Homebase
职责：
根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作
根据临床试验标准确保临床数据相关文档的准确性、时效性、完整性等
熟悉临床试验操作基本阶段和操作流程，及时反馈相关信息给临床项目团队
要求：
本科及以上学历
医药相关专业
1年以上CRA工作起
良好的英语读写能力，可进行基本对话

IQVIA 艾昆纬 CRA1/CRA2/SCRA
办公地点：所在城市办公室（北上广成都）/其他城市Homebase
职责：
根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作
根据临床试验标准确保临床数据相关文档的准确性、时效性、完整性等
熟悉临床试验操作基本阶段和操作流程，及时反馈相关信息给临床项目团队
要求：
本科及以上学历
医药相关专业
1年以上CRA工作起
良好的英语读写能力，可进行基本对话

Essential Functions
● Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses.
● Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
● Develop and implement plans for measuring and improving employee engagement, ensuring global consistency.
● Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable.
● Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership.
● Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.
● Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.
● Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support.
Qualifications
● Bachelor's Degree Clinical, biological or mathematical sciences or related field, or nursing qualification Req
● 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
● Advanced knowledge of Data Management processes and systems.
● Solid understanding of clinical drug development process and production of Data Management deliverables
● Proven Staff management skills, strong leadership, motivational and influencing skills.
● Strong organizational skills, metrics calculations, and time management skills.
● Strong verbal/written communication skills.
● Ability to work on multiple projects and manage competing priorities effectively
● Effective mentoring and developed coaching skills.
● Ability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities.
● Sound judgment, decision-making and problem-solving skills.
● Ability to establish and maintain effective working relationships with coworkers, managers, and clients
● Ability to follow instructions/guidelines, utilize initiative and work independently.
● Understanding on basic Project Finance (EAC, forecasting, burn-rate monitoring and recognizing & pursuing OOS where appropriate)
● Ability to drive business and financial results – short and long term.
● Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers.
● Demonstrates good judgement in requesting input from senior staff. When requesting input, ensure clearly laying out the issue and required background details, articulating what support is needed; and what are the recommended actions.

● 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 feasibility, site ID, 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 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 feasibility, site ID, regulatory for
individual sites.
● Review, track and follow up the progress, the approval and execution of
documents, questionnaires, CDA/SIF, 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.

1. 为研究中心提供实际支持，***限度地提高患者入组率

2. 与研究中心合作，确定并解决患者招募中存在的困难——确定常见的问题，并与申办方和利益相关方合作提出有建设性的意见以克服入组障碍

3.不定期向研究团队提供有关临床研究中入排除标准的相关培训，必要时为新加入的研究人员进行培训

4. 为临床研究中心的医疗人员提供资源，分享患者识别及防止脱落的***做法和策略

5. 通过现场确定患者筛选流程及入组途径，与相关科室合作，提升研究中心对方案的认识以增加患者入组的潜力

6. 作为临床研究的联络人高效解决相关问题 (就相应试验事宜向申办方、临床研究管理人员及CRO/ ARO提供反馈)

7. 向项目管理团队反馈研究执行过程中的问题

8. 向研究团队提供项目进展报告中关于招募的最新信息

9. 提供准确及时的访视报告
岗位要求：

1. 全日制本科及以上，专业不限，生物医疗等相关专业优先;

2. 有临床试验或对接医院/患者沟通经验者优先，如患者招募/CRC/医药销售/CRA等等。

3. 优秀的人际交往能力，能够与各种各样的人建立融洽的关系

4. 优秀的表达能力

5. 良好的英语能力，可以书面沟通

6. 能够协调跨多个职能部门的活动

7. 能够快速理解情况，并提出多种方案最终解决问题

8. 独立的工作能力和抗压能力，具备上进心

9. 接受全国区域的高频出差

职责：

1. 根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作

2. 根据临床试验标准确保临床数据相关文档的准确性、时效性、完整性等

3. 熟悉临床试验操作基本阶段和操作流程，及时反馈相关信息给临床项目团队
要求：

1. 本科及以上学历

2. 医药相关专业

3. 1年以上CRA工作经验

4. 熟悉GCP法规及基本临床试验流程

5. 良好的学习能力和沟通能力

6. 有效的时间管理和协调组织能

7. 良好的英语读写能力，可进行基本对话

Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Essential Functions
● Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
● Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
● Assist with periodic review of study files for completeness.
● Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
● Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
● Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
● May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
● High School Diploma or equivalent02Req
● 1-3 years administrative support experience.
● Equivalent combination of education, training and experience.
● Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
● Written and verbal communication skills including good command of English language.
● Effective time management and organizational skills.
● Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
● Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
● Knowledge of applicable protocol requirements as provided in company training.

IQVIA 艾昆纬 CRA1/CRA2/SCRA
办公地点：所在城市办公室（北上广成都）/其他城市Homebase
职责：
根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作
根据临床试验标准确保临床数据相关文档的准确性、时效性、完整性等
熟悉临床试验操作基本阶段和操作流程，及时反馈相关信息给临床项目团队
要求：
本科及以上学历
医药相关专业
1年以上CRA工作起
良好的英语读写能力，可进行基本对话

Essential Functions
● Manage staff in accordance with organization’s policies and applicable
regulations. Responsibilities include planning, assigning, and directing work,
assessing performance and guiding professional development, rewarding and
disciplining employees, and addressing employee relations issues and resolving
problems.
● Participate in the selection for hiring new employees by conducting
candidate review and participating in the interviewing process. Ensure that new
employees are properly onboarded and trained.
● Ensure that staff has the proper materials, systems access and training to
complete job responsibilities. Provide oversight for the execution of the
training plan, SOP review and training experiences, as applicable.
● Participate in the allocation of resources to clinical research projects by
assigning staff to clinical studies based on their experience and training.
● Manage the quality of assigned staff's clinical work through regular review
and evaluation of work product.
● Identifies quality risks and issues and create appropriate corrective action
plans to prevent or correct deficiencies in performance of staff.
● Ensures that staff are meeting defined workload and quality metrics through
regular review and reporting of findings as outlined by clinical operations
management.
● May collaborate with other clinical teams and other functional leadership to
manage project related challenges and to achieve exemplary customer service.
● Participates in corporate or organizational departmental quality or process
improvement initiatives.
Qualifications
● Bachelor's Degree Degree in scientific discipline or health care preferred.
Pref
● Prior clinical trial experience including experience in a
management/leadership capacity or equivalent combination of education, training
and experience.
● In-depth knowledge of applicable clinical research regulatory requirements
(i.e., Good Clinical Practice (GCP) and International Conference on
Harmonization (ICH) guidelines).
● Good leadership skills.
● Computer skills including proficiency in use of Microsoft Word, Excel and
PowerPoint.
● Written and verbal communication skills including good command of English.
● Excellent organizational and problem solving skills.
● Effective time management skills and ability to manage competing priorities.
● Ability to establish and maintain effective working relationships with
coworkers, managers, and clients.

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