Clinical Research Associate
- Permanent
- Clinical Operations, Project Management
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Hobson Prior is currently recruiting for a Clinical Research Associate to join a leading pharmaceutical organisation on a permanent basis in London. Our client is committed to providing life-changing therapies that can be developed for use in health services throughout the world.
Please note that to be considered for this role you must have the right to work in this location.
Job Responsibilities:
- Set up includes trial start up activities such as ethics submissions, site feasibility, site contract negotiations, and supporting the Clinical Project Manager in vendor selection, and development of study tools.
- Accountable for the set-up, monitoring, and close-out of clinical trial sites for assigned clinical projects.
- Monitoring includes site selection/qualification, routine monitoring, and site close-out visits conducted per the Monitoring Plan.
- Produce accurate and complete monitoring reports and site communications following monitoring visits.
- Accountable for verifying compliance with the Clinical Trial Protocol, GCP, and other relevant requirements at the site.
- Ensuring that non-compliance and any other issues are detected promptly, and reported, resolved and escalated as required, in compliance with project plans, local regulations, and SOPs.
- Ensures that the Investigator Site File at trial sites is maintained correctly, and accurately, and regularly reconciled with the TMF.
- Utilise systems to track status including investigator and ethical review board information, patient recruitment activity, informed consent documentation and ongoing issues at each assigned site.
- Co-ordinate and track site/other payments and maintain records.
- Resolve site issues/questions or escalate issues in a timely and appropriate manner.
- Establish strong constructive relationships at sites.
- Other tasks, duties, and job responsibilities may be assigned based on trial needs.
Key Skills:
- Excellent interpersonal, verbal and written communication skills (including ability to explain information and teach others).
- Ability to manage varied tasks and prioritize workload with accuracy and attention to detail.
- Ability to set priorities and handle multiple tasks simultaneously.
- Able to take initiative and work independently; sense of urgency in completing assigned tasks.
- Ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
- A good team player.
- Flexibility towards work assignments and travel, as considerable travel, including overnight stays is required.
- Excellent oral and written communication skills.
- Highly methodical and organized, including time-management skills and changing priorities.
- Client facing, and customer service experience/skills.
Requirements:
- A degree level in biological science, pharmacy or other health related discipline preferred or equivalent nursing qualification/experience required.
- At least 2 years' experience in working as a CRA, monitoring across all types of visits.
- Keeps up to date with scientific advances, expertise and best practice.
- Familiar with UK regulatory environment and NHS operational requirements.
- Previous experience working in a regulated environment and familiarity with detail of GCP regulations.
- Advanced Therapy Investigational Medicinal Product monitoring experience preferred.
- Experience of working with or in the NHS clinical trial structure in the UK.
- Must also be flexible to travel between sites in London and Stevenage.
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.
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