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 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.
As part of our Functional Solutions team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
Key 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 at TFS
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.
Qualifications
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 opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Securing the Path from Science to Life