Clinical Research Associate

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solutions.

Join Our Team as a Clinical Research Associate (CRA)

About this role

As part of our Strategic Resourcing Solutions (SRS) team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The CRA is responsible for the initiation onsite and remote monitoring and termination of investigative sites during study conduct according to company policies SOPs and regulatory requirements.

The CRA may conduct all stages of site monitoring (feasibility prestudy initiation interim and closeout). Ability to travel as needed: may involve overnight and international travel.

Key Responsibilities:

• Monitor onsite and remotely clinical trials in accordance with TFS and/or client company.
• Standard Operating Procedures FDA regulations and GCP and ICH guidelines.
• Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data.
• Identify site problems/deficiencies and bring to the attention of management through trip reporting memos and verbal communication with Project Manager or Lead CRA.
• Initiates corrective action to resolve issues as directed by supervisor.
• Contribute to the completion of the application to Ethics Committee/IRB prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager.
• Participate in contract handling and negotiation directed by Lead CRA/Project Manager.
• ...

Qualifications:

• Bachelors Degree preferably in life science or nursing; or equivalent.
• Minimum 13 years of relevant clinical experience.
• Able to work in a fast paced environment with changing priorities.
• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess the understanding of Good Clinical Practice regulations ICH guidelines.

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.