Junior Clinical Research Associates

At the moment, to our office in Bratislava, we are looking for: Junior Clinical Research Associates.

As a Junior CRA 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, liaise
with vendors and other duties, as assigned.
Responsibilities:
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities
 Ensure the study staff who will conduct the protocol have received the proper materials
and instructions to safely enter patients into the study
 Ensure the protection of study patients by verifying that informed consent procedures
and protocol requirements are adhered to according to the applicable regulatory
requirements
 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
 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

In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.

For more information and to apply online visit www.careers.covance.com quoting the appropriate reference number - 46256BR.
EEO Employer 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.