Senior Clinical Research Associate (SCRA)

Job Background:

The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking an experienced field based SCRA to work for our client, a leading Pharma company; they need someone to work on an Oncology study. Freelance or employed by Chiltern.

Job Primary Functions:
To undertake monitoring and/or co-monitoring of clinical study sites participating in sponsored studies in accordance with ICH/GCP guidelines and SOPs/WPs and to ensure quality of data from such sites are acceptable and suitable for regulatory submission.

Site set-up, initiation, monitoring and close-out for early-phase oncology studies in UK. This will be performed according to Company SOPs, current ICH/GCP guidelines and local regulatory requirements.
The CRA will primarily be responsible for 4 UK sites for the assigned study but would also be available for support on other Oncology studies as required.
All site co-ordination activities will also be undertaken; including drug accountability and data resolution and the CRA will assist the site in Ethics Committee submissions and preparation of informed consent forms. The CRA will be responsible for the quality of the data for those sites to which he or she is assigned as monitor.
The position is home-based, reporting to a Company Study Manager(s) based in the UK.

Job Qualifications:

Candidates MUST have experience as a CRA/SCRA in the UK. Candidates need to be available from Mid Sept for Initiation visits.
We're looking for a senior CRA with solid experience and the ability to work autonomously, although training will be provided on company processes.
With at least one year in oncology and preferably some early-phase oncology experience.
Location: Field based in the UK, location in UK not critical but needs to have ready access to four UK sites based in London (2), Manchester and Glasgow and potentially other sites within the UK.
Availability: from mid Sept 2012
Duration/contracts: Initial contract for 12 months, renewable
FTE (4+ sites, intensive study schedule, plus support to other studies within the UK)

Keywords:

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