Description
Key Responsibilities include:The Senior CRA will work closely with the Chief Medical Officer, the Project Manager and the Clinical Study Manager to ensure that clinical activities are on target and that clinical study milestone delivery remains on target regarding time, cost, quality and in accordance with SOPs, ICH/GCP guidelines and local regulations:
- The CRA will assist in CRO and vendor management and oversight including attendance at regular clinical and project team meetings
- Perform co-monitoring visits and review monitoring visit reports.
- Assist in in development of clinical study plans and manuals and ensure CRO compliance
- The CRA will assist in coordination of the monitoring of all trials, ensuring that data are entered into the database and cleaned in a timely fashion.
- Assist in coordination of data reconciliation between different databases
- Support project management to ensure CTM / IMP distribution
- Assist in TMF and essential document management
- Ensure that all aspects of GCP are complied with by the CRO
Technical Experience
- The ideal candidate should have minimum of 3 years-experience in a clinical research setting either in the area of pharmaceuticals or biotechnology or within the NHS. Experience in Oncology is essential
- Understanding of drug development process
- Excellent knowledge of GCP
- Experience with clinical systems such as CTMS, EDC, IVRS, Oracle Clinical or other related technology in the pharmaceutical/biotechnology industry
This is an excellent opportunity to work for a fast moving organisation, offering competitive daily rates.
If you are interested in this position and would like some more information please send an updated CV and call Hailey on .
Please also pass this opportunity onto anybody you know who may be interested in this as we do offer £200 referral vouchers.