associate clinical research scientist in leeds

posted
job type
contract
salary
£ 70,000 per year
apply now

job details

posted
location
leeds, yorkshire and the humber
job category
pharmaceutical
job type
contract
working hours
Full-Time
salary
£ 70,000 per year
reference number
ACRS
apply now

job description

Are you an experienced Associate Clinical Research Scientist? Are you looking to take on a new challenge with a leading Medical Devices Manufacturer? If so we are looking for individuals just like you!

We are looking for Associate Clinical Research Scientist to provide support to the implementation of the clinical research operations programme. You will be planning & implementing a programme of monitoring for all international regulatory and post marketing clinical research studies and maintaining the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.

The Therapy area's for this role is Electrocardiophysiology and joint replacement, using surgical instruments and cranial stents etc. This role can be home based or office based, there will be frequent travel in the UK and Europe.

This opportunity is a contract role, initially for 12 months, working 37 hours per week Mon-Fri.


Responsibilities:



* Provide support to EMEA Monitoring Resource Manager and act as the lead monitor within the EMEA region. Provide feedback on current and best monitoring practice, procedural and regulatory compliance, and system adoption (e.g. electronic TMF and Clinical Trial Management System (CTMS)
* Perform monitor observation visits throughout the EMEA region and provide feedback to EMEA Monitoring Resource Manager
* 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
* Maintain compliance with Company SOPs
* Maintain a high standard of housekeeping and filing accuracy
* Occasionally carry out presentations on clinical study progress

Experience/Qualifications Required:



* 1st 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

Other:



* Conditions: Frequent visits to hospitals
* Frequent travel throughout the UK, possibly Europe.

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.