Clinical Research Coordinator(CRC)(职位编号:03)
始达(上海)医药科技有限公司
- 公司规模:50-150人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-11-05
- 工作地点:上海-徐汇区
- 招聘人数:若干
- 工作经验:二年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:临床研究员
职位描述
Position objective:
The Study Coordinator has the authority to run the protocol on a day-to-day basis. The Study Coordinator will have sufficient education, training, and resources available enabling them to perform in this role.
Major responsibilities:
1. Responsible for implementation as well as completion of protocol specific requirements.
2. Provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements.
3. Assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion.
4. Understand and abide by the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.
5. Continuous monitoring of progress in terms of the status of the protocol, reporting back to assigned personnel, updating management staff as well, via weekly and / or other required reports.
6. Monitor the overall day-to-day conduct of assigned protocols in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
7. Creates as well as utilizes charts, spreadsheets, and /or any other appropriate tools enabling the continued, accurate, up to date management of protocol related tasks.
8. Responsible for all protocol specific closeout activities in conjunction with the Clinical Research Assistant assigned to the specific study.
9. To participate in the recruitment and screening of research patients
10. To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events
Competency/Quality Requirement:
1. Nursing Graduate or equivalent, preferably with clinical research or nursing experience
2. Strong project management skills, ability to manage project activities effectively
3. Preferably with 2 years clinical research or patient care working experiences with attention to details
4. Good spoken and written English capabilities with excellent communication skills
5. Willingness to take on new challenges and think with flexibility
主要职责:
1. 负责临床研究按方案要求实施;
2. 在研究过程中,向团队成员提供准确、及时的信息;
3. 协助维护所有与研究有关的CRF;
4. 按照方案要求监察项目进展,并向相关人员报告;
5. 参与受试者的招募和筛选;
6. 与申办方保持密切的联系,参与患者入组、用药、实验室检查异常结果和不良事件报告等。
任职要求:
1. 护理学或医学相关专业本科以上学历,有临床研究经验或医院护理工作经验的优先考虑;
2. 良好的沟通技巧和独立工作能力。
The Study Coordinator has the authority to run the protocol on a day-to-day basis. The Study Coordinator will have sufficient education, training, and resources available enabling them to perform in this role.
Major responsibilities:
1. Responsible for implementation as well as completion of protocol specific requirements.
2. Provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements.
3. Assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion.
4. Understand and abide by the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.
5. Continuous monitoring of progress in terms of the status of the protocol, reporting back to assigned personnel, updating management staff as well, via weekly and / or other required reports.
6. Monitor the overall day-to-day conduct of assigned protocols in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
7. Creates as well as utilizes charts, spreadsheets, and /or any other appropriate tools enabling the continued, accurate, up to date management of protocol related tasks.
8. Responsible for all protocol specific closeout activities in conjunction with the Clinical Research Assistant assigned to the specific study.
9. To participate in the recruitment and screening of research patients
10. To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events
Competency/Quality Requirement:
1. Nursing Graduate or equivalent, preferably with clinical research or nursing experience
2. Strong project management skills, ability to manage project activities effectively
3. Preferably with 2 years clinical research or patient care working experiences with attention to details
4. Good spoken and written English capabilities with excellent communication skills
5. Willingness to take on new challenges and think with flexibility
主要职责:
1. 负责临床研究按方案要求实施;
2. 在研究过程中,向团队成员提供准确、及时的信息;
3. 协助维护所有与研究有关的CRF;
4. 按照方案要求监察项目进展,并向相关人员报告;
5. 参与受试者的招募和筛选;
6. 与申办方保持密切的联系,参与患者入组、用药、实验室检查异常结果和不良事件报告等。
任职要求:
1. 护理学或医学相关专业本科以上学历,有临床研究经验或医院护理工作经验的优先考虑;
2. 良好的沟通技巧和独立工作能力。
公司介绍
始达(上海)医药科技有限公司
始达(上海)医药科技有限公司于2011年9月正式成立。公司致力于临床试验机构管理服务,尤其是抗肿瘤药物早期临床试验的管理。公司的使命是通过高效高质的管理服务,加速创新药物的研发,目标是成为中国临床试验机构的***合作伙伴以及机构管理服务领域的标杆企业。
2011年创立至今,公司分别与多家研究机构合作,协助研究中心进行各临床试验项目的启动前期准备、启动、实施、结束的各项工作。从医学撰写、中心培训、独立质控、项目管理、招募分流、项目协调、数据录入、样本管理等几个维度对临床试验进行嵌入式的管理。
始达欢迎有志迎接新挑战、新机遇,有创业精神的人士加入始达医药,在帮助社会的同时实现自我价值的提升。
请将中英文简历发至邮箱:min.zhou@startshanghai.cn
联系人:董琪
电话: 13524116560
始达(上海)医药科技有限公司于2011年9月正式成立。公司致力于临床试验机构管理服务,尤其是抗肿瘤药物早期临床试验的管理。公司的使命是通过高效高质的管理服务,加速创新药物的研发,目标是成为中国临床试验机构的***合作伙伴以及机构管理服务领域的标杆企业。
2011年创立至今,公司分别与多家研究机构合作,协助研究中心进行各临床试验项目的启动前期准备、启动、实施、结束的各项工作。从医学撰写、中心培训、独立质控、项目管理、招募分流、项目协调、数据录入、样本管理等几个维度对临床试验进行嵌入式的管理。
始达欢迎有志迎接新挑战、新机遇,有创业精神的人士加入始达医药,在帮助社会的同时实现自我价值的提升。
请将中英文简历发至邮箱:min.zhou@startshanghai.cn
联系人:董琪
电话: 13524116560
联系方式
- Email:min.zhou@startshanghai.cn
- 公司地址:东明路1800号
- 联系人:董琪