Clinical Trial Associate
hace 5 meses
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TFS HealthScience is a leading global mid-size 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.
**Join Our Team as a** **Clinical Trial Associate**
**About this role**
- As part of our _**_Strategic Resourcing Solutions_**_ team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals._
The **Clinical Trial Associate **is responsible for organizing and maintaining the Study Master File (SMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.
**Key Responsibilities: (Max 5-6)**
- Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF, ensuring GCP compliance.
- Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from PM/ Lead CRA or CRA.
- Maintenance of electronic files
- Set up the Investigator’s File as directed by the CRA.
- Point of contact regarding SMF
- Maintain the SMF as directed by the Lead CRA/Project Manager
**Qualifications: (Max 5-6)**
- Bachelor’s Degree preferred
- Knowledge of GCP/ICH guidelines
- Good written and communication skills
- Good organizational skills
- Good software and computer skills
- Able to work in a fast paced environment with changing priorities
**What We Offer**
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll 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 full-service, global Contract Research Organization (CRO), we build solution-driven 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 decision-making 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.
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