天津招聘

We are always looking for talented clinical research professionals for Global Site Services Specialist in Beijing. If you are already working in the clinical trial industry in study site management, we want to talk to you about your career development.

Covance is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Development Services team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds – giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global trials. Whether you’re ready to make a move or just interested in learning more, apply today and let’s talk!

About the Job:
Global Site Services Specialists prepare all the material and start up needed for the study according to Covance SOP, GCP, and ICH guidelines, you should have more than 2 years Clinical Research Associate experience before you apply for it. Responsibilities include:

? Develop project specific plans for the GSS component of assigned studies, liaise with operational project team regarding project issues (i.e., participate in team meetings)
? Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
? Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
? Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
? Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility, and obtain further detailed information regarding potential proposals
? Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report

Requirements:
? University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
? 3 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
? Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
? Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
? Good organizational and time management skills, excellent communication / writing skills
? Self-motivation with the ability to work under pressure to meet deadlines, works well independently as well as in a team environment

About Covance:
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 11,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.


Why Covance?
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

We welcome your application and believe this decision may be the most rewarding career move you will ever make!

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/