We are looking for a Clinical Research Associate to cover an exciting opportunity with Scottish Life Science Company.
JOB TITLE: Clinical Research Associate
DURATION: 12 months
RATE: £34.87 per hour
SUMMARY OF POSITION:
- Provide support to the implementation of the clinical research operations programme for the Clinical Operations Franchise 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.
- Minimum Education Requirements:
1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
- Minimum Experience Requirements:
1-2 years (senior 3-4 years) experience of clinical trials management in a medical company preferably with medical devices.
- Minimum Skill Requirements:
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.
- Equipment or Machines Used
Personal computer and general office equipment.
- I will endeavour to get back to you as soon as possible, if I think that your profile fits the description on this occasion.
- But if I don't get back to you, please understand that the volume of responses I get back sometimes doesn't allow me to speak to every person.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales