长沙招聘

工作职责:

Assist the investigators to perform all kinds of clinical research activities in accordance with GCP and study protocol.

根据GCP和研究方案要求，协助研究者完成各项临床研究工作。

(a) Assist investigators to complete EC documents submission and filling, contract signing; Timely assist in

completing the reporting of safety reports including SAEs, SUSARs and other relevant documents.

Documents should be complete, with correct version, and do not exceed the reporting time limit.

协助研究者完成伦理资料递交、机构备案及合同签署等工作；协助及时完成SAE及SUSAR等相关

安全报告上报工作，确保资料完整、信息真实、版本正确、不超时限等基本要求。

(b) Assist the investigators in trial-related documents collection, classification and archive and so on at all

stages. In accordance with the requirements of GCP file management and confidentiality. Be easy to retrieve.

协助研究者完成试验各个阶段研究中心的文档收集、整理、归档等，符合GCP档案管理要求及保密要求，

并易于检索。

(c) Assist in the management of subjects, including recruiting screening potential eligible subjects,

arranging subject visits, laboratory tests and fetching corresponding results. Supervise and urge the

progress of enrolment, and guarantee subject visits as scheduled; and out-of-window visit rate and

drop-out rate should meet or no more than the project requires or the current basic level. Ensure the

source documents of subjects are complete and properly kept.

协助研究者完成受试者管理工作，包括受试者招募、筛选潜在的受试者、安排受试者访视、安排实验室各项检查、获取检查结果等；督促入组进度，并确保访视及时、避免超窗及脱落率符合/低于方案要求或符合当下的基本水平，确保受试者原始资料完整，保管妥善。

(d) Assist investigators in the processing, storage and delivery of test samples to ensure samples

should be processed in time and stored appropriately.

协助研究者完成试验标本的处理、保存和运送工作，保证标本处理及时、保存完好、运送安全。

(e) Assist the investigators in the management and counting of clinical trial drugs and related materials,

including applying for, receiving, storing, distributing, recovering and returning investigational drugs and relevant materials, and making relevant records. Clinical trial drugs should be kept properly and distributed correctly; records are complete, timely and accurate.

协助研究者完成临床研究药物及其相关物资的管理和计数，包括药物及其相关物资的申请、接收、保存、分发、回收和归还，并完成相关记录；妥善保存药物，正确分发，记录完整及时准确。

(f) Assist in the filling of CRFs and resolution of queries with the authorization of investigators

(non-medical judgment).Fill in the CRF timely, true data and accurately with few queries. Ensure queries to be answered within time limit, etc.

在研究者授权下协助研究者填写病例报告表及差异解决（非医学判断类），确保填写及时准确、数据真实、质疑少，质疑回复在时限内完成等。

(g) Establish good partnership with investigators and improve their satisfaction when assisting the

investigators in completing clinical trials.

在协助研究者完成临床试验的过程中，与研究者建立良好的合作关系，提升研究者满意度。

(h) Coordinate with CRA and assist in site visiting, prepare various documents for monitoring, deal with the

Findings of monitoring timely. Files should be complete and accurate, promote the level of satisfaction

from CRA.

协调CRA的中心访视工作，提前准备各种文档供CRA监查，及时解决处理监查发现。文档完整、准确、

提升CRA满意度。

(i) Communicate (verbally, or via email and fax) and document such communication with all study site

personnel and Sponsor/CRO according to study plans. Record and submit communication record timely in according to requests.

按照试验计划与中心人员及申办方/CRO等进行全面的沟通（邮件、口头、传真），及时记录且按照要求提交沟通记录。

任职资格:

(a) Academic / Major 学历/专业

Junior college or above in Nursing, Medical, Pharmacology or Biology related major.

大专及以上学历，护理学、医学、药学、生物制药相关专业。

(b) Requirements for Professional Knowledge/Skill专业知识/技能要求

Understanding of basic medical knowledge.

具有一定的医学相关知识。

Receipt of GCP training, passing of examination and obtaining of certificate

参加GCP培训并通过考试且获得证书

Basic mastery of the CRC’s work flow (through training or teaching)

（通过培训或带教）基本掌握CRC的工作流程。

(c) Working Experience 工作经验要求

No clinical experience or CRC (CRA) work experience within half a year. Those with work experience

as pharmacist, nurse and medical technician as well as clinical study related experience preferred

无临床经验或CRC（CRA）工作经验半年以内。有药师、护士及医疗技师工作经验者优先考虑，有临床

研究相关经验者优先考虑。

(d) Language ability 语言能力

CET-4(Colleges should achieve the same level as CET4), CET-6 is preferred.

英语四级（专科需达到四级同等水平），六级优先。

(e) Computer Literacy 电脑相关知识

Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

熟练使用Word, Excel, PPT, Outlook等办公软件。

(f) Other abilities such as Communication skills\Information-gathering skills本职位要求的其他能力：如沟通能力\信息收集能力等。

Detail-oriented关注细节。

Good communication and coordination skills.

良好的沟通与协调能力。

Good time management skills.

良好的时间管理能力。

Good problem analysis and solving skills.

良好的问题分析与解决能力。

Positive attitude to work.

积极向上的工作态度。

Cultural values: Integrity, honesty, professionalism, openness and tolerance, responsibility.

文化价值观：正直诚信、实事求是、敬业合作、开放包容、专业担当。

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