Clinical Trial SME

• Firecrest Clinical is part of the ICON plc Group and produces highly visual and engaging products for the Clinical Trial Industry. Firecrest products help improve Site performance by delivering innovative and effective training to sites while complying with Industry Standards. As an organisation responsible for the development of clinical training for medical staff, the Clinical Trial Advisor role is critical to the delivery of accurate and high quality training products to our clients.

What you will be doing 

• Uses clinical research experience, accrued from previous clinical research roles, to assist colleagues in the production of accurate and engaging components for our stakeholders.
• Works actively, independently or with the team (depending on the task), to create the high quality digital solutions in line with the sponsor's needs and expectations, and within sponsor delivery timelines.
• Advises and supports the production team (Instructional Designer, Graphic Designer, Product Testing Analysts) on clinical trial related matters, across therapeutic areas.
• Ensures technical accuracy of the products/solutions at each stage of the product development, while ensuring the clinical content adds maximum value for end users (Sponsors, Site Staff, Investigators, and Patients).
• Conducts comprehensive review of study documentation provided by the sponsor
• Attends sponsor meetings and assists Project Manager (PM) as required to support product development
• Communicates/escalates protocol-related queries to the Project Manager (PM)/In Team Lead (ITL).
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• Assumes additional responsibilities as directed by CTSME Supervisor and/or other management.
• Identifies operational efficiencies and process improvements, contributing to an environment of continuous learning and improvement.
• Depending on level of experience, assists in training and mentoring of less experienced CT SMEs.
• Ensure the maintenance of a high personal level of knowledge concerning current regulation and changes within the clinical research industry by means of internal support and individual learning.

Your profile 

• B.Sc. (Hons) in life science or equivalent.
• Minimum 2-3 years' experience as a CRA/site coordinator/study nurse within the clinical research industry
• Experience across different trial phases and therapeutic areas
• Excellent practical knowledge and understanding of the complexity of clinical trials and experience with different clinical trial systems/vendors
• Excellent analytical skills and attention to detail
• Ability to work independently as well as part of the project team, depending on the solution requirements
• Ability to produce accurate work within tight deadlines
• Knowledge of ICH GCP guidelines and experience in reviewing study-related documentation
• Excellent written and verbal communication in English