Clinical Research Associate

Job Details

A leading Global Pharmaceutical company are presently looking to bring in a highly experienced CRA to be based remotely in the UK.

Role Purpose :
An entry role. To collaborate in the identification, selection and monitoring of investigator sites with supervision, in compliance with Client's SOPs, ICHGCP and the UK Statutory Instrument, so that site performance targets are achieved and that the company's image with its external customers is enhanced

Monitoring
Conduct SDV and ensure clinical trials data is submitted to data management in a timely fashion, with supervision.

Management of Investigator Sites
Manage a number of studies and investigator sites commensurate with experience, with supervision, so that studies are run efficiently, and key study objectives are met
Ensure studies are run in line with ICHGCP, the UK Statutory Instrument and SOPs and procedures
Responsible for all aspects of site management from collaboration on site selection to study close-out, with appropriate mentoring and support
Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team, with appropriate mentoring/support.
Interact with health care professionals in a manner which enhances Client's credibility with the customer.

Reporting
Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.
Maintain accurate site-level information on corporate clinical trials registry

Documentation
Obtain critical information to enable generation of IIP documentation
Assist CTA in gathering IIP documentation where required to ensure timely site set up.
Maintain the SMF, and SMF log.
Maintenance of ELARA to ensure audit trail is complete and accurate
QC relevant documents on ELARA in a timely manner

Qualifications
Life science/nursing graduate or equivalent. Experienced CTAs or site co-ordinators who can demonstrate appropriate knowledge may be considered.
Awareness of ICHGCP and UK Statutory Instrument
Computer literacy (word processing and spreadsheets)
Full driving licence.

To Apply:

To apply, please click on the Apply button. Ideally, please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Luke Webber on +44 (0) 207 440 0635 or upload your CV on our website. Full description available on request.

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Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.