北京招聘

Responsibilities:
Manage small projects under direction of a Project Manager/Director as assigned.
Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
Review progress of projects and initiate appropriate actions to achieve target objectives.
Organize and make presentations at Investigator Meetings.
Report, write narratives and follow-up on serious adverse experiences.
Participate in the development of protocols and Case Report Forms as assigned.
Participate in writing clinical trial reports as assigned.
Interact with internal work groups to evaluate needs, resources and timelines.
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
Responsible for all aspects of registry management as prescribed in the project plans.
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; 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.
Undertake feasibility work when requested.
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned.
Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.
Assist with training, mentoring and development of new employees, e.g. co-monitoring
Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
Perform other duties as assigned by management.

Requirements

· Bachelors preferred; or Associate degree in allied health with appropriate experience

· (RN,MT)

· Minimum 2 years of clinical research experience with at least 1 yearsof monitoring experience. Those with 2 to 3 years' experience will be considered for CRAII position.

· Oncology experience strongly preferred

· Experience with EDC/ eCRFs is a plus

· Strong working knowledge of GCP/ ICH and other applicable regulatory guidelines

· Working knowledge of data management practices

· Working knowledge of document management practices relative to assuring quality of essential documents and other study-related documents

You can refer and submit CV by system or email to calvin.xu@covance.com

You are strongly encouraged to visit our recruitment website as http://careers.covance.cn/

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/