Clinical Research Associate
Russell Oakley is recruiting for a CRA to join a company in the Medical Device industry at their site based in the West Midlands on a contract basis.
The main purpose of the role will be to:
Provide support to the implementation of the clinical research operations programme for the company in accordance with all applicable regulations for Medical Devices.
Plan & implement a programme of monitoring for all international regulatory and other 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.
Provide support to Clinical Operations for agreed projects by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.
Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions or amendments for the approval of clinical investigations to regulatory authorities and ethics committees.
Assist 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.
Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
Participate 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 Operations team management.
Maintain compliance with Company SOPs.
Maintain a high standard of housekeeping and filing accuracy.
Further responsibilities will include:
- 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:
Successful planning and execution of monitoring of clinical research projects has a direct bearing on present and future profitability and the maintenance of good relationships with key customers.
This is an excellent opportunity to join a Medical Device company.
For more information or to apply for this position, please contact Russell Oakley on 01246457733 or email on email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical 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 CL34608 in all correspondence.