Clinical Research Associate (m/f)

Description

• You'll be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial (clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects)
• Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• Identifying and assessing the suitability of facilities to be used as the clinical trial site and 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 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) and collecting completed CRFs from hospitals and general practices
• Writing visit reports and filing and collating trial documentation and reports
• Ensuring all unused trial supplies are accounted for
• Closing down trial sites on completion of the trial and archiving study documentation and correspondence

• You need to have either a degree or postgraduate qualification in nursing, life sciences or medical sciences
• Excellent communication skills (both written and oral)
• Ability to build effective relationships with trial centre staff and colleagues
• Fluent English and German language skills
• Good organisational, IT and administrative skills - the job involves a lot of documentation and recording of information through computerised processes such as clinical trial management systems and electronic data capture
• In addition, you must understand the importance of good clinical practice (GCP)

• Home office/Remote possible