北京招聘

Job Description
Clinical Project Assistant
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world.
Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
Covance's ongoing success offers team members unsurpassed growth and career development opportunities. There's no better time to join us!
I. Job Summary:
? Conducts site monitoring of clinical research studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
? Provide clinical support for projects according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
? Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.

A. Duties and Responsibilities:
? Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned.
? General On-Site Monitoring Responsibilities:
a) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
b) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
c) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
d) Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
e) Prepare accurate and timely trip reports.
? Responsible for aspects of site management as prescribed in the project plans.
? Responsible for aspects of registry management as prescribed in the project plans.
? Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management.
? Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management.
? Provide coverage for clinical contact telephone lines, as required.
? Update, track and maintain study-specific trial management tools/systems.
? Generate and track drug shipments and supplies, as needed.
? Track and follow-up on serious adverse events as assigned.
? Implement study-specific communication plan as assigned.
? Attend investigators' meetings, project team meetings and teleconferences, as needed.
? Assist Senior CRA in managing investigator site budgets.
? Perform other duties as assigned by management

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/