Job Opportunities

Date: 2013-11-27
Company: Tecnimede
Area: Ensaios Clínicos
Ref. : CRA/13
Availability: Horário Completo - Admissão Imediata

Clinical Research Associate (M/F)

Applications are invited for a Clinical Research Associate (CRA) to integrate the Medical Department of an international pharmaceutical company.

The CRA will report to the Clinical Trial Project Managers and his/her main responsibilities will include:

  • Compiling pre-submission clinical documentation;
  • Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing off all trial subjects;
  • Managing regulatory authority applications and approvals;
  • Locating and assessing the suitability of facilities at a study center;
  • Briefing doctors/consultants (or investigators) on conducting the trial;
  • Setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial specific and industry standards;
  • Monitoring the trial throughout its duration, which will involve visiting the study centres on a regular basis;
  • Verifying that data entered on to the CEFs is consistent with patient clinical notes, known as source data/document verification (SDV);
  • Collecting completed CRFs from hospitals and general practices;
  • Writing visit reports;
  • Filling and collating trial documentation and reports;
  • Ensuring all unused trial supplies are accounted for;
  • Closing down study centres on completion of the trial;
  • Archiving study documentation and correspondence;
  • Preparing final reports and manuscripts for publication in indexed scientific journals.
    This area of work is open to graduates with a degree in pharmaceutical sciences. Potential candidates will need to show evidence of the following:
  • Work experience (at least 2 years) in a similar position;
  • Fluency in English;
  • Excellent communication skills (both written and oral) and the ability to build effective relationships;
  • The ability to motivate others;
  • Numeracy;
  • An eye for detail;
  • Ability to multi-task;
  • Good organizational, IT and administrative skills.
    Please send your application letter and CV in English (Ref. CRA/13)

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