CRA - Fieldbased
CK Group is recruiting for a Clinical Research Monitor to join a world leading medical device company at their site based in Leeds on a 12 month contract basis.
This role is filed based but will be covering the North of England and Scotland.
Providing support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for in accordance with all applicable regulations for Medical Devices. Planning & implementing a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.
- Providing support to EMEA Monitoring Resource Manager and acting as the lead monitor within the EMEA region. Providing feedback on current and best monitoring practice, procedural and regulatory compliance, and system adoption (e.g. electronic TMF and Clinical Trial Management System (CTMS)).
- Performing monitor observation visits throughout the EMEA region and providing feedback to EMEA Monitoring Resource Manager.
- Providing support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
- Assisting in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
- Monitoring defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
- Administering the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
- Participating in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.
- Maintaining compliance with Company SOPs.
- Maintaining a high standard of housekeeping and filing accuracy.
- Presentations on clinical study progress.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.· Experience of clinical trials monitoring in a medical company preferably with medical devices.
- Knowledge of clinical study design and management.
- Above average oral, written and communication skills.
- An interest in oversight/ CRA Management.
For more information or to apply for this position, please contact Lucy Stendall or Jenni Woolley on 01246 457733 / 01438 768 710 or email firstname.lastname@example.org. Alternatively please click the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45247 in all correspondence.