Clinical Research Associate

Title: Clinical Research Associate
Position type: Permanent, Full time
Location: Home based, UK travel will be required
Reports to: Clinical Project Manager

Role and responsibilities
– To support the preparation of the necessary study ethics, R&D, regulatory and site specific submission packages as required, to address any queries raised relating to these submissions and to ensure approvals are in place prior to study start
– To support the set-up of study sites, including ensuring each site has the necessary study materials and other resources to conduct the study
– To develop key study documents including informed consent forms, data
management plans, case report forms, study specific SOPs, etc.
– To set up study files and organise study related documents within P1vital and at study sites
– To develop and maintain strong working relationships with site investigators and study site staff, promoting study recruitment strategies
– To conduct study monitoring and other data checking activities, as required
– To verify that data entered into CRFs is consistent with source documents
– To perform study drug accountability, monitor study drug storage conditions and ensure pharmacy documentation is up-to-date
– To review on regular basis throughout the study conduct the Investigator Site File and the Pharmacy File for completeness and ensure the site is filing all documents on an ongoing basis to be inspection ready
– To check site delegation list is always up-to-date and signed off by the PI and that any new staff member has received adequate training prior to their involvement in the study
– To write study visit reports and status reports
– To file and collate study documentation and reports
– To support the close-out of study sites
– To archive study documentation and correspondence
– To identify training and/or process issues at study sites
– To provide training and guidance for the clinical research teams at study sites
– To provide operational advice and guidance on studies being conducted
– To assist and support Clinical Project Manager(s) in dealing with site and study management tasks
– To author and/or review company SOPs and guidelines as required

Skills and experience
– Graduate with life sciences or equivalent degree
– A minimum of 2 years prior CRA experience working in a clinical trials environment
– Knowledge of ICH-GCP
– Excellent communication skills (both written and oral)
– Ability to multi-task and problem solve
– A concern for quality, attention to detail and accuracy
– Good organisational, computer and administrative skills
– Proactive contribution towards the team by being a flexible team player
– Ability to motivate others
– Ability to work independently in a fast-paced environment

If you are interested in applying for this role please email your CV with a cover letter to recruitment@p1vital.com.