Parkside recruitment are pleased to be recruiting a Clinical Trials Administrator for our client within the Pharmaceutical sector with a document management background to organise, maintain and complete Administration supporting clinical operations project managers on day-to-day study management activities and clinical operations functions ensuring they are supported in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
You will have:
- Substantial administrative experience or qualified to degree level. Scientific background is essential.
- Experience or knowledge of regulatory documents or medical terminology is essential
- Experience in clinical operations area related work is essential.
- Must have working knowledge of computer applications including Microsoft project.
- Must be organised and detailed-oriented.
- Able to produce work of high quality in a timely manner.
- Up-to-date Good Clinical-research Practice training.
- Organise, maintain and complete the paper and electronic trial master files, including collation of study documents from monitors, appropriate filing of documents.
- Identify, request and ensure delivery of outstanding and outdated documents.
- Periodically, and at the end of the study, review study files / folders for organisation and completeness.
- Assist in setting up clinical study files / folders at study sites and assist in quality review of the study site files / folders throughout the study.
- Assisting by offering support for day-to-day study management activities
- Tracking the distribution of protocols and protocol amendments.
- Creating drafts of study-specific documents.
- Seeking signatures for approved documents.
- Conducting in-house clinical operations functions, including clinical supplies coordination
- Assisting the investigator meeting preparation and coordination, document processing and study status tracking.
- Arranging and minuting Study Team Meetings (as required) and completing actions as necessary.
- Assist in the project management and monitoring of clinical studies, including liaison with study sites, monitors, drug vendors, central laboratories and other vendors for study related tasks.
- Perform various study related functions as required and assigned to ensure the accurate, quality, timely and on budget execution of clinical studies, to include:
- Maintaining budget tracking tools as appropriate.
Parkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.