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Clinical Research Associates

CV MARKET´S CLIENT

Darbo skelbimas negalioja

Darbo skelbimo numeris 76820

Darbo skelbimo numeris

76820

Job Description

* Responsible for all aspects of study site monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaise with vendors and other duties
* Ensure the study staff has received the 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
* Responsible for all aspects of site/registry management as prescribed in the project plans
* 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
* Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.


Requirements

Experience. Typically required :


* Minimum of one (1) year of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
* Fluency in Lithuanian and English
* Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process
* Good planning, organization and problem solving abilities
* Good communication and interpersonal skills
* Available for travel up to 40% to 60% of the time, including overnight stays as necessary


Education. Typically required :


* University/college degree (life science preferred), or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology)
* Alternatively, candidates with two or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered as well
* A valid driving license.


Company offers

At Covance, we help make the miracles of medicine a reality.
We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
Client-office-based or home based with some home-office tasks if required.



Additional information

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.
APPLY ONLINE


Location:
Vilnius
Job type:
full-time, employee
Expiration date:
03 December 2009
Published:
03 November 2009

CV MARKET´S CLIENT

Covance is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries.
Due to our continuous growth, we are looking for enthusiastic and experienced