An excellent opportunity has opened up to join a world-wide leading ophthalmic research organisation. They are seeking a Lead CRA to join them on a permanent basis in London where you will be fully remote based with up to 25% travel (primarily in the UK but may have the opportunity to travel to the EU).

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be responsible for independently customising and maintaining the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
• Ensuring overall project efficiency and adherence to project timelines; report metrics and out-of-scope activities to the CRA line Manager, Sponsors, or Clinical PM's.
• Working closely with other functional groups within the company such as data management, project management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
• Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to the assigned clinical project management leaders.
• You will produce and present training to clients, colleagues, and professionals, as required.
• Conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively escalate quality or non-compliance issues to Monitoring Management.
• Handle escalations for site management questions and issues for assigned projects.
• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives
• Host routine CRA team calls with a focus on best practice / knowledge sharing
• Provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable
• Supports audit and inspection activities as needed and may assist with on-site CRA training and evaluation upon request.
• Clear and sustained demonstration of this company's Clinical's Values of prioritizing kindness, a commitment to rigorous science, cultivating joy and honoring our commitments.
• Travel Requirements up to 25%.
• Responsibilities may differ slightly from the above based on specific needs of the business.

Key Skills:

• Strong attention to detail in order to review CRA visit reports.
• Ophthalmic experience strongly preferred.
• Understand how to properly assess an investigative site's capabilities for conducting clinical research.
• Ability to monitor and report on the progress of the trial from start-up to completion. Knowledge of how to select and qualify an investigative site.
• Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits.
• Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Multilingual communication is a plus.

Requirements:

• You will require a bachelor's degree with 5 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience. Years of experience may be considered in lieu of education
• Prior team and/or site lead experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.