This is a PAYE salaried role - permanently EMPLOYED by Chiltern, a COVANCE company
- You would be contracted out to a top ten pharmaceutical company - full time (or possibly 4 days/week if preferred) office based at junction 4 of the M3 in Surrey. The office is immediately next to the M3 Motorway. In late 2019 - the office will move to London (near Paddington)
Completing IRAS, HRA and R&D submissions for new clinical trials.
Negotiating site contracts and budgets.
Collecting, reviewing, processing and tracking regulatory & investigator documents required for study site activation in accordance with company and Sponsor SOPs, ICH GCP guidelines, EU Clinical Trials Directives, FDA Regulations and the Investigator Package Plan.
Reviewing of patient information sheets and informed consents for compliance to international and country requirements and protocol.
Preparing, reviewing and submitting initial and amended submissions to Research Ethics Committees.
Assessing impact of site personnel changes and/or study amendments on regulatory documents and process/review new documents according to ICH/GCP guidelines.
Communicating regularly with start-up and clinical project managers, clinical trial leads, CRAs and CTAs via site status reports, CTMS, phone and email.
Liaising directly with Sponsor local affiliates regarding site progress, contracts and budgets
To provide an efficient and professional ethics and R&D set up service within required timelines according to company SOPs and ICH GCP guidelines and to provide advice and knowledge to project managers and clinical associates regarding the ethics / regulatory processes in the UK and Republic of Ireland.
The role would suit candidates who are particularly interested in study start up activities in the UK and Republic of Ireland. If you have awareness of the current MHRA regulations for ethics submissions and R and D approvals this will be a major advantage in your application. We particularly welcome applicants from within the NHS who have clinical trials start up expertise in perhaps a governance role and who are looking to make the move into commercial pharma operations.You may have been a study site coordinator or clinical trials coordinator for example OR research nurse OR perhaps a CRA who is now looking for an office based role with minimal travel
We definitely need someone who can work autonomously and be accountable/responsible for a successful site activation. You must be an excllent communicator with good negotiation skills and a drive for success.
All qualifications considered.
We are looking for someone who has experience in the start up environment already. This is not a trainee role.