Clinical Trial Associate (CTA)

About this role

TFSHealthScience is a leading global mid-size Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservice-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 Investigators 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

Bachelors 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.