|Location: Leeds, West Yorkshire||Salary: £35.00 - £40.00 per hour|
|Sector: Medical Devices||Specialism:|
|Type: Contract||Contact: Matt Henocq|
Clinical Research Monitor
Provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for my clients Medical Devices in accordance with all applicable regulations for Medical Devices. Plan & implement 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.
- Provide 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.
- 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 for the approval of clinical investigations to regulatory authorities and ethics committees.
- Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
- 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 Trial Leader & monitoring team.
Knowledge and experience:
- Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
- 5+ years experience of clinical trials monitoring in a medical company preferably with medical devices.
- Knowledge of clinical study design and management. Relevant experience in implementation of clinical research studies. Working knowledge of international regulatory requirements applicable to clinical research. Awareness of research ethics. Above average oral, written and communication skills.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.