Clinical Trial Associate
Clinical Trial Associate
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Job Description
About this role
TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities resourcing and Functional Service (FSP) solutions.
The Clinical Trial Associate (CTA) manages and maintains essential study documents including the Study Master File (SMF) and coordinates documentation and contractrelated tasks throughout clinical studies ensuring strict adherence to company policies SOPs and regulatory standards.
As part of our SRS/FSP team you will be dedicated to one sponsor a global pharmaceutical/biotech company that is an industry leader in (fill in detail)
Key Responsibilities
- Assist in preparation and distribution of trialrelated documents tools and templates.
- Support regulatory submissions and amendments (IEC/IRB/CA) and manage related processes.
- Assist with contract management Investigator Payments and documentation tracking
- Coordinate study supplies and documentation as delegated by the CRA/Project Manager.
- Initiate maintain and close the Study Master File (SMF) in compliance with GCP.
- Set up and maintain study information in the Clinical Trial Management System (CTMS).
Qualifications
- Experience in clinical trial administration preferably within a global setting.
- Knowledge of clinical trial documentation regulatory requirements and GCP.
- Strong organizational and communication skills.
- Experience working with contracts and study documentation.
- Ability to coordinate multiple tasks and collaborate with crossfunctional teams.
What We Offer
We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.
Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.
Employment Type
Full Time
