https://www.cvkeskus.ee/191573

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Clinical Research Associates

CV MARKET´S CLIENT

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Tööpakkumise number 191573

Tööpakkumise number

191573

Job Description

  • be 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
  • be responsible for all aspects of site/registry management as prescribed in the project plans
  • be responsible for recruitment of potential investigators, involvement in EC submissions and 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

  • Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
In lieu of the above requirements, candidates with three (3) years of site management and/or study co-ordinator experience will be considered.
  • 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 planning, organization and problem solving abilities.
  • Ability to work with minimal supervision.
  • Good communication and interpersonal skills.
  • Good analytical and negotiation skills.
  • Computer competency.
  • Fluent in local office language and in English, both written and verbal.
  • Works efficiently and effectively in a matrix environment
Preferred:
  • One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.

Education:

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.
Preferred:
  • Thorough knowledge of Covance S.O.P.s for site monitoring.


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.



Additional information

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. This is your chance to become part of a team that helps to bring miracles of medicine to market sooner.

Please apply:
http://www.applytracking.com/x.aspx?track=2aNq0Lh7wH52MB%2bSX37hIvfoXkq0pIRqNOrnJnsaWnK1dyARsCTHpuM%2b%2b%2fGUmdTcdl0YM%2b0f%2f0sW8YgupCEi5w%3d%3d


Location:
Tallinn, Harjumaa
Job type:
full-time, employee
Expiration date:
15 March 2010
Published:
19 February 2010

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 an enthusiastic and experienced