[上海]煌途（北京）科技有限公司

福利:专业培训 职能类别:生物工程/生物制药 职能类别:临床研究员

岗位职责：

The Clinical Trial Assistant (CTA) has the responsibility for the successful delivery of the assigned clinical research tasks within his/her defined territory under the supervision of the (A)CRM/(A)CRD.

1. Key Accountabilities

1.1 Project Related Accountabilities

· Provide general administrative support to the clinical study team and assistance

to Project Managers (PMs).

· Assist the clinical study team in completion of all required tasks to meet

departmental and project goals.

· Support the clinical study team with ongoing conduct of studies.

· Be familiar with ICH-GCP, appropriate regulations, relevant SOPs and internal

tracking systems.

· Be familiar with the roles and responsibilities of the CRA including site

visits, if appropriate.

· Assist project teams with study-specific documentation and guidelines as

appropriate.

· Set up, organize and maintain clinical study documentation (e.g., Trial Master

Files, CRFs, etc.) including preparation for internal/external audits, final

reconciliation and archival.

· Process Data Collection Forms, i.e., logging in, tracking and quality

controlling as appropriate for the study.

· Coordinate ordering/dispatch and tracking of project materials (e.g., CRFs,

diary cards, lab supplies, IP supplies) as appropriate.

· Assist in the tracking and distribution of safety reports.

· Coordinate document translation, if required.

· Attend project team meetings and generate meeting minutes.

· Assist in the production of slides, overheads, etc., as needed for project,

departmental, sponsor and/or business development presentations.

· Other duties as assigned by PMs/CRMs/CRDs.

1.2 Relationship Management

· Be responsible for contributing to the establishment of a strong team spirit.

任职要求：

· Results Driven Behavior

· Self‐motivation and adaptability

· History of successful drug supply management

· Ability to form strong alliances with internal and external stakeholders and among study team members

公司名称:煌途（北京）科技有限公司 公司类型:民营公司 公司规模:150-500人 公司介绍:  Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .    We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.   We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).  We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.   公司邮箱：ling.zhang@   公司网址：ww***com[点击查看]