Closing Date: 15 Feb 17
Type: Full Time
Salary (£): Negotiable
Here at QuintilesIMS we are looking for an experienced CTA to work for our single sponsor client. This role will be based out of their Luton offices. We are looking for someone with previous clinical trial administrator experience to assist in the coordination and administration of clinical studies from start-up through to close out. ...
Here at QuintilesIMS we are looking for an experienced CTA to work for our single sponsor client. This role will be based out of their Luton offices.
We are looking for someone with previous clinical trial administrator experience to assist in the coordination and administration of clinical studies from start-up through to close out.
Provide administrative support to clinical projects under direction of line manager, Clinical Research Specialist and/or other designated clinical team members. Assists with general administrative functions as required.
• Coordinate, prepare, review and track documents for the application process.
• Interface with investigators, external service providers and CRAs during the collection process
• Main contact for CRAs and the Study leaders during study team meetings, monitor meetings and investigator meetings until finalization of the study
• Ensure payments are made in compliance to regulation and paid in a timely manner
• Set-up, populate and maintain information in tracking communication tools, and support with usage of the systems in each study
• Set-up the local Trial Master File (eTMF) with reviewing, approving and uploading of documents following the ICH/GCP compliance and local requirements and support CRA in ISF activities
• Maintain study documents by localizing templates with version compliance
• Contribute to applications and submissions for effective publishing and delivery to regulatory authorities, such as, local ethics committees and the MHRA.
• Create and import clinical-regulatory documents into the Global Electronic Library (GEL)
• Assisting in the provision of professional and patient materials
• Manage initial set up and access requests for trial site staff to various study systems
• Tracking patient recruitment, withdrawal and sample collection
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
? Knowledge of applicable protocol requirements as provided in company training
? Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
? Good written and verbal communication skills including good command of English language
? Effective time management and organizational skills
? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience; or equivalent combination of education, training and experience
? Extensive use of telephone and face-to-face interactions, which require accurate perception of speech
? Extensive use of keyboard requiring repetitive motion of fingers.
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
? Regular sitting for extended periods of time.
? Occasional travel.
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