上海招聘

（高级)临床观察员（Senior）CRA

RESPONSIBILITIES:
1. Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
2. Acts as primary local company contact for assigned sites for specific trials.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies
10. Ensures site staff complete the data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.


EDUCATION AND EXPERIENCE REQUIREMENTS:
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 2 years of clinical trialmonitoring experience is preferred.
Specific therapeutic area experience may be required depending on the position.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication skills.

上海复星医药（集团）股份有限公司（简称“复星医药”，证券代码600196），前身为上海复星实业股份有限公司，成立于1994年，1998年8月在上海证券交易所挂牌上市。
复星医药专注现代生物医药健康产业，经过十余年的发展，在研发创新、市场营销、并购整合、人才建设等方面形成了核心竞争力，已成为以药品研发制造为核心，并在医药流通、诊断产品和医疗器械等领域拥有领先规模和市场地位的大型专业医药产业集团。

在中国，复星医药已经取得肝病药物、妇科药物、糖尿病药物、临床诊断产品、口腔治疗机等细分市场领先地位，在药品分销领域稳居第一，在药品零售市场国内领先；在国际市场的抗疟药物、特色原料药等领域发展迅速。

当前，复星医药正以中国医药市场的快速成长和欧美主流市场仿制药的快速增长为契机，加快实施“创新、品牌、成本、全球化”战略，稳健经营、快速发展。

面向未来，复星医药将继续以人类健康为己任，注重人才与团队建设，不断创新，持续优化与整合医药产业链资源，从外延式发展走向内生性发展，积极提升企业在全球医药产业的竞争力，力争早日实现成为全球主流市场上一流企业的战略目标。