clinical research monitor in leeds

posted
12 April 2019
contact
ruby willard, randstad cpe
job type
contract
salary
Competitive
apply now

posted
location
leeds, yorkshire and the humber
specialism
pharmaceutical
sub specialism
Production
job type
contract
working hours
Full-Time
salary
Competitive
reference number
CTMJL
contact
ruby willard, randstad cpe
apply now

job description

Are you looking for a new role as a Clinical Research Monitor? Do you want to be responsible for providing support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for our clients Medical Devices in accordance with all applicable regulations for Medical Devices? If the answer is yes, this role is for you!

You will be 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.

This is a new contract opportunity to play a key role and work for a leading Medical Devices manufacturer based in Leeds. There will be frequent visits to hospitals, and frequent travel throughout the UK, possibly Europe.

Benefits:



* Free on site parking
* On site gym
* Subsidised restaurants and branded coffee shops
* Competitive pay
* Weekly pay
* Pension contributions

Duties:



* Provide support to the 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
* Maintain compliance with Company SOPs
* Maintain a high standard of housekeeping and filing accuracy
* Occasionally present on clinical study progress.

Experience and qualifications:



* 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
* 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

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.