任职要求/岗位职责
Job description1. Conduct clinical trials according to ICH-GCP, company SOP and regulatory requirement2. Produces comprehensive visit reports3. Handle CRF collection, query resolution and SAE reporting in a timely manner4. Collect and maintain all necessary document5. Adherence to the timelines and budget6. Maintain good relationship with the investigators7. Do feasibility study according to sponsor’s requirement8. Sr.CRA will also be involved in coaching the junior CRAs, and developing monitoring tool.Requirement:1. Bachelors Degree or above, majoring in medical, pharmaceutical or bio-science.2. 1-2 years CRA experience, international trials experience preferred.3. Clinician experience preferred.4. Good written and verbal communications skills both in Chinese and English5. Good computer skills.6. Self-motivated, have team-spirit, can work under pressure.7. Can travel frequently, up to 60%.
企业介绍
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@ht-med.com
公司网址：http://www.ht-med.com
