Description
An Interim CRA is needed for an initial 6 month contract to join a leading Medical Device company.Job Specifications:
- 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.
KEY TASKS
1. The CRA must provide support to CPL for agreed projects in the International 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.
2.Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.
3.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.
4.Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
5.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.
6.Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
7.Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
8.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 CPL & monitoring team.
This is an excellent opportunity to work for a fast moving organisation, offering competitive hourly rates. If you are interested in this position and would like some more information please send an updated CV and call Hailey on .
Please also pass this opportunity onto anybody you know who may be interested in this as we do offer £250 referral vouchers.