An exciting new opportunity with a well renowned Research Institution in central London is now available.
We need an expert Office Based Lead Clinical Research Assistant, with experience in team management as well as study start-up, site initiation, regulatory and monitoring in Real World data through to site and study close-out.
Experience preferred would be Cardiology (other TA experience will be considered) You should be passionate about remote study monitoring and using technology to help oversee and monitor sites of observational studies ensuring compliance with Standard Operating Procedures (SOPs) and policies, European Union Directives whilst they still apply, UK legislations and other regulatory requirements are met and maintained at all times.
For this long term contract we are looking for a candidate who has had a solid career background as a CRA .
Some of the required Experience and skills As Lead CRA

• A strong communicator at any level
• Point of contact for defined tasks during study and supports COO and CPMs with communication as directed
• Ensure investigator site contact details generated, co-ordinated and maintained
• Logistics of investigator and monitor meetings organised including the development of presentation materials under direction of CPM
• Management of Trial Monitors / Clinical Research Assistants
• Take responsibility when required for the setting up of new trial in the UK
• Adapting global documents for UK patients - PIS, consent forms, SOPs and monitoring manuals,
• Responsible for UK site approvals, conducting feasibility assessments, SIV, training
• Accompany Trial monitors on SIVs and monitoring visits. Review and sign off monitoring visit reports.
• Identify barriers to participation in studies and develop strategies with the operations team, Project Managers and Principal Investigators
• First point of contact for issues relating to ethical and regulatory applications, pharmacovigilance issues
• Liaison with and application to the Networks
• Ensure the development of 'best practice' in patient recruitment and other key areas are disseminated amongst trial sites and investigators so benefits are shared as widely as possible
• In collaboration with Research Services, oversee the negotiation of the contracts for each new site
• Assist with the production of key documents, plans and reports, including metrics, financial plans and reports and annual reports
• Contribute to communications and data dissemination including the preparation and delivery of presentations, reports and newsletters to the Investigators and staff.
• To ensure high ethical standards are maintained at all times and there is full compliance with all applicable laws, regulations, codes and internal policies and procedures
• Awareness of and compliance to laws and regulations applicable to projects
• Awareness of and compliance to all policies and procedures including Finance, Procurement, IT and Legal
• Demonstrable ownership of comprehensive understanding of regulations and SOPs: Learning gaps identified and actions taken to access required training
• Attendance at all requisite training sessions and completion of all requisite on-line training and compliance programmes within specified time limit

Qualifications and right to work
Education & Experience

• BSc in Life Science Field or equiv
• Experience working in a CRO, biotech or pharma company at SENIOR CRA or equiv
• Excellent organisational skills
• Excellent spoken and written English
• Languages a massive bonus!

Must already have the right to live and work in the UK.

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