TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
About this Role
As a Senior Clinical Research Associate with TFS HealthScience, you will be an integral part of our SRS/FSP team, working exclusively with a world-renowned global pharmaceutical/biotech sponsor. Your role will be critical in ensuring the quality and integrity of clinical trials, driving them forward from start to finish.
The Senior Clinical Research Associate is responsible for the initiation, on-site and remote monitoring, and termination of investigative sites during study conduct, according to company policies, SOPs, and regulatory requirements.
Key Responsibilities:
- Conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed, which may involve overnight and international travel.
- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, GCP, and ICH guidelines.
- Review CRFs (paper or electronic) and subject source documentation for validity and accuracy, generating queries to investigational sites/clients to resolve data issues.
- Identify site problems/deficiencies and report them to management through trip reports, memos, and verbal communication with the Project Manager or Lead CRA.
- Initiate corrective actions to resolve issues as directed by the supervisor.
- Contribute to the completion of applications to Ethics Committees/IRBs, preparing necessary documentation according to local requirements in cooperation with CTA and as directed by the Lead CRA/Project Manager.
Qualifications:
- Bachelor’s Degree, preferably in life sciences or nursing, or equivalent.
- Minimum 1-3 years of relevant clinical experience.
- Ability to work in a fast-paced environment with changing priorities.
- Understanding of basic medical terminology and science related to the assigned drugs and therapeutic areas.
- Familiarity with Good Clinical Practice regulations and ICH guidelines.
- Ability to work independently as well as in a team-oriented environment.
- Excellent written and verbal communication skills in English and Polish.
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You will 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, including Poland, with flexible clinical development and strategic resourcing solutions across key therapeutic areas such as Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in attracting and retaining valuable talent who share our vision. These values drive high employee engagement and satisfaction. By aligning with these fundamental principles, 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.
