Job Title: Senior Clinical Research Associate - Berkshire
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Vacancy details
Vacancy description:
Job Code:
J237334
Job Title:
Senior Clinical Research Associate - Berkshire
Job Category:
Clinical Research
Contract:
Permanent
Discipline:
CRA, Clinical Study Coordinator, Clinical Study Admin
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Oxfordshire, Surrey, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
05 Sep 2008
A FANTASTIC OPPORTUNITY TO WORK WITH A FAST GROWING MEDIUM SIZED GLOBAL PHARMACEUTICAL COMPANY AS A SCRA / JUNIOR PROJECT MANAGEMENT ROLE. THIS POSITION WILL ALLOW YOU TO STEP AWAY FROM MONITORING TO WORK CLOSELY WITH CRO'S IN DELIVERING PROJECTS
The role of a Senior CRA (SCRA) is to take a leadership role in overseeing specific aspects of individual clinical studies, working under the guidance of the Project Manager (PM), to ensure the quality and integrity of data and safe and proper management of study parameters. A SCRA will also provide daily support to the Project Manager (PM) and be the first point of contact on clinical issues in the absence of the PM. Working closely with CRAs and Project Managers, key responsibilities include:
To become competent on all appropriate technical and medical requirements of the study
To proactively assist the PM in delivery of projects
Oversee the study monitoring team to ensure compliance with ICH-GCP guidelines, applicable country regulations and SOPs
To help resolve study related queries from other CRAs or external providers
To effectively co-ordinate CROs and other external providers to ensure their optimal on-time performance and compliance with ICH GCP, international guidelines and SOPs
To co-monitor clinical trials that have been outsourced to CRO(s) to ensure consistency with the protocol and monitoring procedures across all CRAs/sites
To train and mentor less experienced CRAs in procedures and monitoring activities
To play a key role at Investigator and monitor training meetings
To conduct feasibility studies for new projects
To assist the PM in the CRO and provider selection process
To perform clinical monitoring activities for designated projects as required
To support Regulatory, Safety and Writing functions and Senior Management as required
To support and input into processes and procedures
Keywords - Senior Clinical Research Associate Berkshire SCRA Lead Clinical Resaerch Associate Monitering South East Junior Project Manager
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