南京招聘

联斯达职业发展部招聘CRA,Outsource to Global Pharma .

工作职责（Job Responsibilities）：

1.Monitoring Site Selection: Prepare, conduct and report on pre-study visits; Identify potential investigators and check Site staff/facility qualifications.

2.Monitoring Site Initiation: Prepare, conduct and report on Site Initiation visits ;Ensure investigator has submitted regulatory documents to IEC as required; Co-ordinate shipment and review storage/dispensing of IP and other study related materials; Negotiate CSA & FA with investigators.

3.Monitoring Study visits: Prepare, conduct and report on Site Monitoring visits; Review overall site performance to identify site problems in quality or delivery and take action accordingly; Ensure investigator’s adherence to protocol and GCP; Review Informed Consent Forms and IEC documents; Review SAE reports and ensure reporting has occurred if appropriate; Review Data query resolution.

4.Monitoring Study closure: Prepare for, conduct and report on Study Closure visit; Retrieve CRFs; Ensure regulatory documents available and updated; Ensure IP, study material accountability, return and disposal if required; Ensure study report submission to EC; Ensure final payment processed to investigators; Resolve outstanding queries and issues.

5.Investigator, study team and monitors meetings: Attend meetings when required; Organize venue, dates and invites for investigator meetings; Prepare content and deliver presentations at meetings.

任职要求(Job requirements)：

1.Essential: Bachelor degree of Science or above.

2.Desirable: Medical /pharmacological/Nursing/Science background.

3.Full understanding of GCP.

4.Able to establish and maintain excellent relationships and partnerships with investigator site staff and study team members.

5.At least 1 year working as a CRA in Pharmaceutical clinical research.

6.Clinical research experience in pharmaceutical companies or CROs.

7.Fluent English in reading, writing and speaking(At least 4 level).

8.Familiar with MS office software (Word, Excel, PPT, etc).

9.Work at sites and travel frequently.

10.Work independently；Basic coaching skill；Excellent communication skill；Team work spirit.

●关于联斯达●



联斯达是国内临床研究现场管理组织（SMO）领导者之一，中国GCP联盟优秀成员，DIA中国SMO协作组暨“中国CRC之家”的第二届主任委员单位，是中国率先进入互联网化管理的第三方独立专业的临床研究现场管理组织（SMO）。

联斯达率先获得ISO9001质量体系认证，通过了多个Global CRO和Pharma的系统稽查，并获得了供应商资格。联斯达致力于发展成为中国***的临床研究现场质量控制管理专家，“722” CFDA核查期间，联斯达项目100％通过。

联斯达与中国600多家医院达成了稳定的合作关系，总部设在北京，在南京设有分公司，并在上海、南京、广州、杭州、成都、哈尔滨、合肥、武汉、西安等城市建立办事处，拥有1200多名员工，覆盖中国城市110+，至今服务项目达950+，85%为1类新药和生物制品，擅长肿瘤、内分泌、心脑血管、抗感染和风湿免疫领域。



●关于康龙化成●



康龙化成新药技术股份有限公司(股票代码：300759)，成立于2004年，是国际领先的生命科学研发服务企业。经过十多年的快速发展，康龙化成打造了全方位的药物研发一体化平台，贯穿合成与合成及药物化学、生物、药物代谢及药代动力学、药理、药物安全评价、放射标记化学、放射标记代谢、临床药理、临床分析、原料药和成品药的工艺优化及生产、临床CRO等领域。

康龙化成在中国、美国、英国均有运营实体，拥有6,800多名员工，一流的人才队伍，高质量的研发服务，获得了业界的广泛认可，与北美、欧洲、日本和中国的各医药公司/机构保持着长期、稳固的合作关系。