Clinical Trial Associate/Clinical Study Administrator (One Sponsor)

• The opportunity to be part of a friendly, supportive team and work with exciting technologies
• Home based flexibility (2 days/week)
• Competitive salary
• Private Health Coverage
• BUPA Cashplan
• Corporate Pension Plan
• Life Insurance
• Global General Liability Insurance

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• Collects, assists in preparation, reviews and tracks documents for the application process.
• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH- GCP and local requirements.

• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Sets-up, populates and accurately maintains information in TFS tracking and communication tools (e.g. CTMS such as IMPACT, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).

• Commute to the office location in Luton, England
• High school/Secondary school qualifications, that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Administrative (CTA/CSA) experience in the CRO/ pharma field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written English.
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with a good understanding of the ICH-GCP guidelines.
• Ability to develop advanced computer skills to increase efficiency in daily tasks.
• Good verbal and written communication.
• Good interpersonal skills and ability to work in an international team environment.

TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.