长沙招聘

Job Summary:

1. Manage the development and coordination of monitoring activities in China for assigned projects with minimal supervision.

2. Oversees trial related training of study sites.

3. Reviews results and initiation of additional measurements at the external site, if results are outside the expected range

4. Cooperate with other departments which are involved in the project throughout the study.

Main Tasks & Responsibilities:

1. Participate in the development of the protocol, protocol revisions, amendments and CRF development.

2. Develops the study monitoring plan, and ensures compliance with visit frequency and all assigned tasks throughout the study.

3. Ensures availability and delivery of reagents/materials/samples to sites

4. Perform training of the external study personnel in the use of the instruments and reagents, and software packages for the on-line data capture and for computer based evaluation, eg. with WinCAEv and training in the use of electronic CRFs with remote data entry

5. Independently performs monitoring visits, including Site Assessment, Initiation, interim monitoring and Close-out visits in accordance to RPD SOPS and the monitoring plan.

6. Ensures studies are performed, recorded and reported in accordance with protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.

7. Coordinate and supervise site monitoring assignments and activities.

8. Develops study specific training materials.

9. Maintain communication with study investigators to ensure studies are completed timely and ensure agreed upon objectives are met

10. Interprets and evaluates results with respect to the study goals and, if necessary, discussion with the site, the study manager and BioMetrics, eg. Interruption of the study or initiation of additional measurements at the external sites

11. Communicates to the Study Manager, monitoring and site management updates or issues.

12. Ensures all documentation is in place at the start and throughout the duration of the study.

13. Participates in Investigator meetings when applicable, attend professional meetings and congresses, if applicable

14. Assist in writing of product information, package inserts and publications for journals and congresses

15. Perform training of the external study personnel in the use of the instruments and reagents, and software packages for the on-line data capture and for computer based evaluation, eg. with WinCAEv and training in the use of electronic CRFs with remote data entry

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.

关于BD

BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者，致力于通过研发创新技术、服务和解决方案，帮助患者改善临床治疗，并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念，致力于帮助提升患者的治疗效果，为临床医护人员提供安全、高效的护理给药流程，协助实验室科学家们更有效地诊断疾病，并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构，与全球范围内的组织机构积极合作，携手应对最具挑战的全球健康问题。通过与客户的紧密协作，BD以改善治疗结果，降低医疗成本，提升诊断效率为己任，帮助加强患者和医护人员的安全并扩大医疗可及性。2017年，BD欢迎巴德及其产品加入BD大家庭。更多信息，敬请访问**********/china。