Job Description :
• To assist the Project Managers in the management and administration of on-going clinical trials.
• To assist in the conduct of Early Phase studies across all therapeutic areas in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP’s).
• Assist the Project Managers in administration and organisational matters.
• General administrational tasks e.g. handling of post/faxes, photocopying, filing.
• Completion and updating of project information on ClinBase.
• Liaison with PAREXEL staff such as the study co-ordinator, Principal Investigator, Pharmacist and recruitment personnel to ensure the smooth running of Early Phase studies
• Liaison with Sponsor personnel ensuring communication channels are open at all times and that the Sponsor is kept adequately appraised of study progress.
• Assisting the Project Manager in ensuring all study milestones are met.
• Assisting the Project Manager in management of project related meetings (both internal and with Sponsor personnel ) and attendance at such meetings where appropriate.
• Assisting the Project Manager with submission of documents to Ethics Committtees
• Assisting the Project Manager with development and review of study protocols.
• Assisting the Project Manager with review of study related documents (including Case Report Forms) and distribution to third parties where appropriate.
• Assisting the Project Manager with distribution of draft documents for review, collation of comments and liaison with Sponsor.
• Assisting the Project Manager with the review of Informed Consent Documents and IRAS application forms in conjunction with appropriate medical personnel.
• Set up and regular review of the Study File to ensure completeness and compliance with GCP guidelines. Assisting the Project Manager in maintaining contact with external sites to arrange transfer of documentation as required.
• Assisting the Project Manager with management of monitoring visits, overseeing the resolution of data queries.
• Assisting the Project Manager in maintaining contact with sub-contracted parties where appropriate to ensure timely study conduct.
• Assisting the Project Manager in ensuring that archive procedures are initiated and followed.
• Assisting the Project Manager with preparation of post-study summary report for the Ethics Committee.
• Participate in general departmental activities to assist in continuous improvement of the department.
• Life Science degree and/or nursing background.