Senior Clinical Research Associate Job in South East England, Southern Uk
About us:
Juice Resource Solutions provide cost effective recruitment solutions.
We supply top tier professionals for both Interim/Contract and Permanent assignments to Global organisations and a diverse range of SMEs
Our highly experienced consultants are dedicated to providing exceptional levels of service and customer satisfaction. We value honesty and integrity and we strive to maintain our reputation as a hard working, results driven organisation.
•Writes and communicates the Clinical Operations Trial Plan and Clinical Monitoring Plan.
•Assures adherence to Good Clinical Practices, Investigator integrity, and compliance with all study procedures.
•Some Line Management of clinical personnel in line with the performance management procedure
•All site co-ordination activities will also be undertaken for pre-study, initiation, monitoring and close-out activities for Phase I through to Phase IV studies in accordance with current ICH/GCP guidelines, local regulatory requirements and SOPs/WPs. This includes documentation, drug accountability, safety monitoring, data resolution and establishing a good site relationship.
•Assists in preparation of protocols, protocol amendments, eCRFs, study manuals, and other related documents used by the clinical study sites during the implementation of studies, as required.
•Prepare and submit UK/Ireland Ethics Committee submissions and coordinate R+D approvals.
•Develops the study specific Informed Consent Form for review and approval by the Sponsor.
•Preparing and submitting UK/Ireland Investigator Contracts (mCTAs in the UK).
•To undertake Project Team Leader (PTL) responsibilities, this entails leading across-departmental team.
•Reviews in conjunction with clinical and/or Data Managers, the quality and integrity of the clinical data through (1) on-site source verification and (2) in house review of electronic CRF data.
•Liaising with Data Management during all stages of a study.
•Responsible for negotiations with outside Vendors/Contractors when necessary.
•Liaising with Database Configurators to assist with eCRF/database design
•Assisting the study Clinical Project Manager (CPM) in updating study metrics, compiling status reports.
Essential Work Experience and Qualifications
•The ideal candidate for this position will be a Science graduate with 4+ years CRA experience
•In-depth ICH/GCP and EU Directives knowledge
•Oncology experience a plus
In-house study management experience a plus
•Deputises for the CPM when CPM unavailable.
•UK travel, and some travel to other European countries and the US on an ad hoc basis.