GxP Recruitment invites applications on behalf of our biotech client in Central Belt of Scotland where an excellent opportunity has arisen for a Clinical Research Associate to join their team on a permanent basis.
**Please note for this role, a minimum of 2 years’ field-based trial monitoring experience in the UK, is required**
The Clinical Research Associate (CRA) will be responsible for the coordination of a variety of clinical trials in oncology (Cell immunotherapy) to ensure the trial is conducted in accordance with ICH GCP and other relevant regulatory guidelines. The trials will be conducted in the UK and EU.
The postholder will take ownership of assigned studies and carry out site selection/feasibility, support to EC/RA submissions, initiations, on-site monitoring, and close-out activities
Key duties include:
* To ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework.
* Experience of performing site start up procedures, routine monitoring and site closure.
* Ability to manage multiple priorities across various clinical trials
* Establishing regular lines of communication plus administering protocol and related study training to assigned site
* Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
The ideal candidate:
* Life science or nursing degree or educational equivalent or equivalent combination of education, training and experience
* Minimum 2 years’ experience of field-based trial monitoring as a CRA
* Thorough knowledge of ICH GCP
* Experience in site set up and regulatory and EC submissions in EU and US would be an advantage
* Experience in haematology, immunotherapy and/or cell therapy would be an advantage
* Thorough knowledge of ICH GCP and other industry-recognised standards and guidelines and conducting clinical trials in general.
* Excellent inter-personal, organisational, presentation and written communication skills
* Proactive approach with high levels of initiative, energy and commitment