J193988
SCRA (office or field based)
Our client is a leading full service clinical research organisation who provides a full range of early and late stare clinical trials.
Job Summary:
Completes project activities associated with monitoring functions of Phase II-III clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations. Provides clinical and technical support for CRA I, CRA II and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).
Main roles:
• Provides clinical and technical support as a mentor for CRAI / CRAII and administrative staff and conducts co-monitoring / training visits.
• When required acts as primary client contact for specific project related activities.
• Performs clinical trial initiation, monitoring and close-out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).
• Assists with protocol review, CRF and informed consent development.
• Completes study start-up activities.
• Develops and implements innovative approaches for site selection, and pre-study activities to identify and evaluate potential investigators.
• Completes site evaluation and reports to Lead CRA / Project Leader as appropriate.
• Completes submission of documents to the Ethics Committees when required.
• Collects, reviews and tracks regulatory documents when required.
• Manage and track investigator grants with study sites when required.
• Assists the Lead CRA with the development of study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents by organizing the efforts of the team CRAs in completing these tasks.
• Assists Lead CRA with organizing and conducting study specific training and attends.
• Develops and implements innovative approaches for the preparation and coordination of investigator meetings and attends.
• Completes pre-study visits with study site staff.
• Provides status updates of pre-study and initiation activities to Lead CRA / Project Leader.
• Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures.
Qualification: BA or equivalent with proven clinical trial monitoring experience in CRO or pharma enviroment.
£TBA p/a
Stephen
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01189594990
Berkshire
Medical Scientific
Clinical Professionals Ltd
119 Hits
SCRA (office or field based) Senior clinical research associate
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