Emergex Vaccines Holdings Ltd.

CRA – Clinical research associate Job Description

 

Assignment: Full-time, Abington Oxfordshire Offices, Preference local (no relocation provided), Permanent

Responsibilities:

  • Develop and write trial protocols (outlining purpose and methodology)
  • Present trial protocols to a Regulatory Authorities and other committees
  • 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
  • Design data collection forms, known as case report forms (CRFs)
  • Assess the suitability of facilities to use as the clinical trial site
  • Proven experience in monitoring and/or coordinating clinical trials preferred; experience in a clinical setting a plus.
  • 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)
  • 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 statistician, who writes technical trial reports
  • Archive study documentation and correspondence
  • Prepare final reports and occasionally manuscripts for publication.

 

Qualifications:

  • A degree or postgraduate qualification in nursing, life sciences or medical sciences.

 

Skills:

  • Excellent communication, both written and verbal, and interpersonal skills
  • Ability to build effective relationships with trial centre staff and colleagues
  • Excellent grasp of numeracy and a keen eye for detail
  • Presentation skills
  • Ability to reason independently and recommend specific solutions in clinical settings.
  • Project management skills
  • A flexible and adaptable approach to work in a biotech environment
  • 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
  • Understanding of the importance of good clinical practice (GCP), which is a legal requirement for all CRAs.
  • Willingness and ability to travel domestically and internationally, as required.