About this role

 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.

The Clinical Trial Associate (CTA) is part of the Clinical Operations or Strategic Resourcing Solutions Unit within TFS Develop and will work, when delegated, as a member of the study team with the responsibility to organize and maintain the Study Master File (SMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.

Responsibilities

 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
 Coordinate study supplies as directed by the CRA
 Drafts and/or assists with the preparation of trial-related documents, tools and templates
 Assist in status reporting
 Arrange internal and external meetings
 Actively taking part in Study Team meetings and be responsible for the minutes
 Prepare, contribute to and distribute presentation material for meetings and newsletter
 Assist in activities associated with audits and regulatory inspections
 SMF completion and preparation of shipment to sponsor as directed by the Lead CRA /CRA
 Collection of appendices for final Clinical Study report
 Actively contribute to the organization and development of routines to enhance the work atTFS
 Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and amendments, regulatory fees
 Assist the CRA, PM or Lead CRA managing contracts with sites, including contract status.
 To manage Investigator Payments as directed by PL or Lead CRA
 Assist the PL with document translations process
 May support the CRAs with some monitoring remote activities: collection of documentation, follow up on data entry, queries resolution

Requirements

 Bachelor’s Degree preferred
 About 2 years of experience working as a CTA 
 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

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.