The Clinical Research Associate is to be the main interface between clinical sites for its ongoing clinical trials and will be responsible for monitoring the progress of assigned clinical trials, provide training and support to the site staff, and report and resolve or escalate problems and any issues occurring at these sites. The trials assigned may be either sponsored or conducted on behalf of its collaborators. This role will report to the Head of Clinical Development and may also report to the (Senior) Clinical Project Manager according to project and team needs.
On offer is a competitive salary and benefits package which includes a bonus, travel expenses paid for and flexible remote working. There is also progression available.
The position is based in central London and would require the candidate to travel to a clinical trial site near Cambridge (on average once a fortnight).
Key Accountabilities of the Clinical Research Associate include:
- Responsible for the set-up, monitoring, and close-out of clinical trial sites for assigned clinical projects undertaken, working to ICH GCP.
- 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.
- 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.
- Responsible 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.
Experience required to be the successful candidate:
- At least 2 years working as a CRA, monitoring across all types of visits - feasibility, initiation, monitoring and close out (essential)
- Familiar with UK regulatory environment and NHS operational requirements.
- Experience working in a regulated environment and familiarity with detail of GCP regulations.
- Advanced Therapy Investigational Medicinal Product (ATIMP) monitoring experience preferred.
- Flexibility towards work assignments and willingness to learn.
- Excellent interpersonal, verbal, and written communication skills (including ability to explain information and teach others).
- Client facing, and customer service experience/skills.
Knowledge / Skills / Competencies:
- Experience of working with or in the NHS clinical trial structure in the UK (desirable)
- Enjoys working in a regulated environment and willing to comply with Standard Operating Procedures and Policies.
- 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.
- Excellent oral and written communication skills.
- Ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
- A good team player.
- Highly methodical and organized, including time-management skills and changing priorities.
- Keeps up to date with scientific advances, expertise and best practice.
- Flexibility towards work assignments and travel, as considerable travel, including overnight stays is required.
- Must also be flexible to cross over between sites in London and Stevenage.
Education / Qualifications
- Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience required.