Clinical Trial Associate/Clinical Study Administrator (One Sponsor)

Overview: TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions (SRS) team and we are looking for an experienced, highly motivated Clinical Trial Associate (CTA) who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS HealthScience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.
Together we make a difference.
TFS HealthScience is looking for a Clinical Trial Associate or Clinical Study Administrator (CTA/CSA) to be office based in Luton (3 days a week).
The CTA will assist in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. This role will be outsourced and dedicated to one extraordinary sponsor!
We look forward to receiving your application soon!
What can we offer you? A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. UK benefits include:

• 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

Responsibilities:

• 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).

Qualifications:

• 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.

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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.