Clinical Research Associate (Cra)

Clinical Research Associate ( CRA)
We are seeking a CRA with experience of monitoring Clinical Trials.
Our Client is a Clinical Research Organisation (CRO) specialising in monitoring clinical trials.
They have helped in the successful completion of 400+ clinical trials involving medical device products. In addition, their medical writers have helped to prepare many scientific papers for publication in international journals.
With a well established network of investigators in Europe and North America, co-ordination of multi-national studies is one of their strengths. As a company that undertakes in-house clinical research as well as multi-site clinical trials, they have a thorough understanding of all aspects of clinical trials.
They are currently searching for a CRA with some experience to manage and monitor clinical studies in Europe and North America from their base near Farnham, Surrey. This full-time position is office-based, potentially with some travel within Europe and North America. The role would suit a CRA with experience in monitoring clinical trials, looking to progress their career and take on more responsibility.
Key Duties and Responsibilities:
• Assist in the preparation of study protocols, CRFs and other essential documents
• Prepare informed consent forms and ethics committee submissions
• Perform site selection, initiation, monitoring and close out
• Manage assigned sites to ensure that timelines, recruitment and quality standards are met
• Maintain awareness of ICH GCP, SOPs and regulatory requirements and ensure adherence by site staff
• Build good relationships with investigators and site staff to raise company profile and ensure full participation in studies
• Communicate effectively both verbally and in writing with investigators, site staff and study Sponsors
•Resolve site non-compliance and any data quality issues
• Assist in the training of clinical personnel
Candidate Requirements/key skills:
• Graduate Life Science qualification or other appropriate degree
• Good working knowledge of ICH GCP and clinical trial methodology
• Knowledge of relevant industry standards and other legislation
• CRA experience of monitoring Clinical Trials essential
• Computer literate
• Excellent interpersonal and organisational skills
• Medical device experience desired but not essential
• The role may suit an individual who was involved in monitoring clinical trials but has had a career break.