Chiltern (a Covance company) has an excellent opportunity (permanent position) - for a home based CRA to work on secondment to a top ten pharmaceutical company. This is a full time position but we may consider 4 days.
Reading in Berkshire, UK may be a good location as the successful candidate would be monitoring to the West (South Wales, South West Pennisula) but maybe a bit East too. The studies will be predominantly in Neuroscience
Chiltern have enjoyed a long and partnered approach with our pharma partner and both organisations are focused on the wellbeing and career development of the individual
Our Pharma partner are officially certified by the Top Employers Institute for its exceptional employee offerings for the fourth consecutive year, and for the first time, Top European Employer
We are looking for a dynamic CRA – an individual who enjoys the thrill of building relationships with sites, is interested in career development.
You will receive full support in terms of line management/pastoral care, full administrative support, and access to excellent training in both soft skills and technical advancement courses.
You would typically be monitoring around 3 days/week. Sites are all very regional so travel distance is minimal but there could be multiple protocols.
Contribute to the nomination of new sites for clinical trials; analyse capability and make recommendation for trial inclusion.
Assume ambassadorial role to facilitate communication between sites and Operations to increase value proposition to investigators
Facilitate preparation and collection of site level documents during all phases of the trial; resolve problems as required
Execute site initiation and training.
Implement total site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance.
Identify problems at sites; resolve issues and escalate as appropriate.
Collaborate with the clinical study manager (CSM) to ensure recruitment and execute contingency plans, as needed.
Complete preparation and generation of study monitoring reports.
Review and manage data remotely and at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
Implement site close-out activities.
Ideally you will have a life science degree and at least 12 months monitoring experience in the UK within either the Pharma or CRO setting. We will also consider monitors who have come from an academic setting or from within the NHS and have taken part in investigator led studies.
The current plan is that studies will be predominantly be Neuroscience but there may be a need/opportunity to support studies in Ophtha and Respiratory as time goes on.
Life science degree preferred and at least 12 months independent monitoring experience within the secondary care environment in the UK.
IMPORTANTLY - We are looking for a CRA who has at least 12 months independent monitoring experience at hospital sites either in the UK or Ireland. You may have been doing this within an academic setting and/or within an NHS trust - that is fine, as long as you have the independent monitoring skills to include site selection, initiation, monitoring and close out.
We’d like someone with experience in monitoring and being a team player is as important as ever.