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CLINICAL RESEARCH ASSOCIATE (CRA)
• Clinical Research Associate also known as
monitor is employed by either a pharmaceutical
company or a contract research organization
(CRO) which works on behalf of pharmaceutical
companies.
• Clinical trials may be carried out at various
phases, trials on patients with a disease, and
studies conducted after the launch of a new
drug to monitor safety and side effects.
• The CRA will be involved in all stages of the
clinical trial, including identifying an
investigation site and setting up, initiating,
monitoring and closing the trial upon
completion or termination.
ROLES AND RESPONSIBILITIES OF CRA:
 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. Training the study staff in standard operating
procedure for the clinical trials as per applicable regulatory
requirements.
CONT…
 Verify that investigator and investigator’s team are adequately
trained and comply with the protocol.
 Verify that IRB/IEC operates and complies as per GCP, SOP and
applicable regulatory requirements.
 Monitoring the trial throughout specified duration involving
monitoring visit to the trial sites.
 Source data verification
CONT…
 Informed consent form review, case report form review,
investigational drug accountability, and adverse event
review.
 Ensuring all unused trial supplies are accounted for.
 Writing visit reports, filing and collecting trial
documentation and reports.
SKILLS:
 Excellent communication skills (both written and oral) and the ability to
build effective relationships with trial centre staff and colleagues
 The ability to motivate others
 An eye for detail
 Ability to multi-task and think on your feet
 Good organizational, IT and administrative skills – job involves lot of
documentation and recording of information through computerized
processes such as clinical trial management systems and electronic
data capture

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Cra responsebility

  • 1.
  • 2. CLINICAL RESEARCH ASSOCIATE (CRA) • Clinical Research Associate also known as monitor is employed by either a pharmaceutical company or a contract research organization (CRO) which works on behalf of pharmaceutical companies. • Clinical trials may be carried out at various phases, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects. • The CRA will be involved in all stages of the clinical trial, including identifying an investigation site and setting up, initiating, monitoring and closing the trial upon completion or termination.
  • 3. ROLES AND RESPONSIBILITIES OF CRA:  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. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.
  • 4. CONT…  Verify that investigator and investigator’s team are adequately trained and comply with the protocol.  Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.  Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.  Source data verification
  • 5. CONT…  Informed consent form review, case report form review, investigational drug accountability, and adverse event review.  Ensuring all unused trial supplies are accounted for.  Writing visit reports, filing and collecting trial documentation and reports.
  • 6. SKILLS:  Excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues  The ability to motivate others  An eye for detail  Ability to multi-task and think on your feet  Good organizational, IT and administrative skills – job involves lot of documentation and recording of information through computerized processes such as clinical trial management systems and electronic data capture