Clinical Research Associate II

At the moment we are looking forward to hire experienced Clinical Research Associate II to join our growing operations in Prague.

As CRA II you will be 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. If you have at least 1 years of experience in monitoring clinical trials, we want to talk to you about this opportunity.


Responsibilities:
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities:
o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
o 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
o implausible data
o 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
• Prepare accurate and timely trip reports
• Responsible for all aspects of registry management as prescribed in the project plans
• 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
• Negotiate study budgets with potential investigators and assist the Covance legal department
• with statements of agreements as assigned
• Complete 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

We Offer:
Covance's ongoing success offers team members unsurpassed growth and career development opportunities at an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package
There is no better time to join us!

Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.

To apply please go directly to Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 37715BR or follow the link:
http://jobsearch.covance.com/jobs/978870-Clinical-Research-Associates.aspx