Clinical Research Associate ( CRA)
We are seeking a CRA with experience of monitoring Clinical Trials. Salary is negotiable and depends on experience (£25-35k)
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 which is not mandatory. 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
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.