CRA (Clinical research associate)

1.Mô tả công việc:

CRA: The CRA will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial ensuring adherence to Good Clinical Practices (GCP), investigator integrity and compliance with all study procedures.

  • presenting trial protocols to a steering committee;
  • coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
  • managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;
  • identifying and assessing the suitability of facilities to be used as the clinical trial site;
  • identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site;
  • liaising with doctors/consultants or investigators on conducting the trial;
  • setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;
  • monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;
  • verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
  • collecting completed CRFs from hospitals and general practices;
  • writing visit reports;
  • filing and collating trial documentation and reports;
  • ensuring all unused trial supplies are accounted for;
  • closing down trial sites on completion of the trial; 
  • archiving study documentation and correspondence;

2.Yêu cầu công việc:

  • excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues;
  • numeracy and an eye for detail;
  • the ability to multi-task and think on your feet; Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
  • good organisational, IT and administrative skills - the job involves a lot of documentation and recording of information Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
  • Ability to contribute to the development of clinical trial related documents and materials
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
  • Willingness and ability to travel

3. Yêu cầu trình độ:

  • Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
  • Clear understanding of the drug development process
  • Work experience within either a hospital, medical / research centre environment, Site Manager Organisation, Contract Research Organisation or Pharmaceutical company
  • Fluency in English language (both written and spoken)

4. Mức lương:Thỏa thuận

(10 triệu với người chưa có kinh nghiệm; 15 triệu với người có kinh nghiệm từ dưới 1 năm; 20 triệu với người có kinh nghiệm CRA từ trên 1 năm)

  • Ngày cần nhân sự: 20 tháng 5 năm 2014

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