Emergex Vaccines Holdings Ltd.
CRA – Clinical research associate Job Description
Assignment: Full-time, Abington Oxfordshire Offices, Preference local (no relocation provided), Permanent
- 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.
- A degree or postgraduate qualification in nursing, life sciences or medical sciences.
- 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.