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成都-临床监查员Ⅱ
10-15K/月四川省-成都/本科及以上/1-3年
王仁平一周前来过
昆翎企业管理（上海）有限公司
职位详情
岗位职责
任职要求：
Primary Responsibilities:
Perform site selection (if applicable), initiation, monitoring and close-out
visits in accordance with contracted scope of work, SOPs (and / or the
Sponsor’s SOPs as appropriate) and the ICH GCP and associated regulations.
May perform co-monitoring visits and other types of site visits as needed.
Support development of project subject recruitment plan on a per site basis.
Work with sites to adapt, drive and track subject recruitment plan to meet
project recruitment target.
Administer protocol and related study training to assigned sites and establish
regular lines of communication with sites, ensure that study milestones for
sites responsible are met as planned with high quality (i.e., study startup,
recruitment, database lock, closeout, etc.)
Create and maintain appropriate documentation regarding site management,
monitoring visit activities by submitting regular visit reports and/or other
required study documentation.
Evaluate the quality and integrity of study site practices related to the proper
conduct of the protocol and adherence to applicable regulations. Take
corrective action and preventative actions to mitigate the risk. Escalate quality
issues as appropriate.
Manage the daily progress of assigned studies by tracking regulatory
submissions and approvals, recruitment and enrollment, case report form
(CRF) completion and submission, Ethics Committee documents submissions
and approvals, study drug management, document filing, site payments, data
query generation and resolution. May support start-up phase and additional
site-self assessment requirements.
Collaborate and liaise with study team members for other project execution
support as appropriate.
Performs additional task as assigned by line manager.
May be assigned as the mentor of less experienced CRAs
Other activities/tasks assigned by supervisors.
Primary Responsibilities:
Perform site selection (if applicable), initiation, monitoring and close-out
visits in accordance with contracted scope of work, SOPs (and / or the
Sponsor’s SOPs as appropriate) and the ICH GCP and associated regulations.
May perform co-monitoring visits and other types of site visits as needed.
Support development of project subject recruitment plan on a per site basis.
Work with sites to adapt, drive and track subject recruitment plan to meet
project recruitment target.
Administer protocol and related study training to assigned sites and establish
regular lines of communication with sites, ensure that study milestones for
sites responsible are met as planned with high quality (i.e., study startup,
recruitment, database lock, closeout, etc.)
Create and maintain appropriate documentation regarding site management,
monitoring visit activities by submitting regular visit reports and/or other
required study documentation.
Evaluate the quality and integrity of study site practices related to the proper
conduct of the protocol and adherence to applicable regulations. Take
corrective action and preventative actions to mitigate the risk. Escalate quality
issues as appropriate.
Manage the daily progress of assigned studies by tracking regulatory
submissions and approvals, recruitment and enrollment, case report form
(CRF) completion and submission, Ethics Committee documents submissions
and approvals, study drug management, document filing, site payments, data
query generation and resolution. May support start-up phase and additional
site-self assessment requirements.
Collaborate and liaise with study team members for other project execution
support as appropriate.
Performs additional task as assigned by line manager.
May be assigned as the mentor of less experienced CRAs
Other activities/tasks assigned by supervisors.
任职要求
无
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公司信息
昆翎企业管理（上海）有限公司
- 上海
- 1000-9999人
- 健康管理机构
- 民营
- 无
昆翎ClinChoice是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO，服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心，目前在全球拥有2000多名员工，其临床运营团队覆盖了亚、欧、北美等七个国家和地区。 昆翎的历史可以追溯到1995年，公司在过去20多年里积累了深厚的临床研究专业经验和监管知识，并在中国、美国、欧洲、印度、日本和菲律宾等多个国家和地区开展了业务。昆翎在其发展旅程中经历过一系列的并购与重组，并成功的融入了昆翎医药、K&L咨询和iMedGlobal。未来，随着生命科学领域的创新发展，昆翎将继续为全球申办方在整个研发、注册和商业化阶段提供高质量的CRO服务。同时，公司将积极与成熟型和成长型的公司展开合作，依靠功能完善的CRO团队帮助申办方实现其本土和全球的战略目标。在全新品牌战略的引领下，昆翎将以“立足中国，服务全球”为己任，继续为全球制药、生物科技和医疗器械公司提供高质量、全方位服务的临床研究服务。 ●成就•迄今为止，昆翎已通过超过 70 家国际知名制药和医疗器械企业的稽查，参与并承担了超过 85 个创新药和近20 个生物类似物的注册申报、临床设计和开发工作•3 年内，昆翎已支持递交美国和欧洲新药证书申请 17 个，已获批 15 个•承接临床研究 1,600 余项，包括多个入组人数达 10,000 例以上的大型临床研究•全球布局的临床试验服务团队，承接国际多中心临床试验MRCT的能力完备•昆翎医药是中国目前创新药临床试验服务经验最为丰富的 CRO 公司之一•昆翎医药临床监查团队已与中国大陆、中国香港、中国台湾和韩国的多家医院建立了广泛联系，合作医院数量达到 1,500 余家•为中国大陆、中国香港、中国台湾和韩国等地的各阶段临床试验入组受试者近 300,000 例
