https://www.cvkeskus.ee/182612

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Clinical Research Associates

CV MARKET´S CLIENT

Tööpakkumine on aegunud!

Tööpakkumise number 182612

Tööpakkumise number

182612

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 Estonian 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)
• In lieu of the above, candidates with at least two (2) 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.


Additional information

Please apply:
http://www.applytracking.com/x.aspx?x=eJltfqTg8%2bVdCQe42g6th29LJDcZ26VuNii2XiFzi3g%3d


Location:
Tallinn, Harjumaa
Job type:
full-time, employee
Expiration date:
14. september 2009
Published:
14. august 2009

CV MARKET´S CLIENT

is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries.