Responsibility

  • Develop and write trial protocols (outlining purpose and methodology).
  • Present trial protocols to a steering committee.
  • Design data collection forms, known as case report forms (CRFs).
  • Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
  • Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.
  • Identify and assess the suitability of facilities to use as the clinical trial site.
  • Identify/select an investigator who will be responsible for conducting the trial at the trial site.
  • Liaise with doctors, consultants or investigators on conducting the trial.
  • Set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP).
  • Train the site staff to trial-specific industry standards
  • Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis.
  • Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
  • Collect completed CRFs from hospitals and general practices
  • Write visit reports and file and collate trial documentation and reports.
  • Ensure all unused trial supplies are accounted for.
  • Close down trial sites on completion of the trial.
  • Discuss results with a medical statistician, who writes technical trial reports.
  • Archive study documentation and correspondence.
  • Prepare final reports and occasionally manuscripts for publication.
Skills Required
  • Excellent communication, both written and verbal, and interpersonal skills.
  • The ability to build effective relationships with trial center staff and colleagues.
  • The ability to motivate others.
  • Strong customer focus
  • An excellent grasp of numeracy and a keen eye for detail.
  • Presentation skills.
  • The ability to multitask and think on your feet.
  • Project management skills
  • A flexible and adaptable approach to work.
  • Organisational, IT and administrative skills - the job involves a lot of documenting and recording information through computerised processes, such as clinical trial management systems and electronic data capture.
  • An understanding of the importance of good clinical practice (GCP), which is a legal requirement for all CRAs.