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.
Join Our Team as a Clinical Research Associate (Freelance, 0.4 FTE)
About this role
As part of our Clinical Development Services (CDS) team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Clinical Research Associate (CRA) is responsible for the initiation, on-site and/or remote monitoring, and close out of study sites during study conduct, according to company policies, SOPs, GCP and ICH guidelines, sponsor requirements, and applicable regulatory requirements.
Key Responsibilities:
• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP and ICH guidelines, and applicable regulatory requirements. Perform all required monitoring activities at study sites to ensure subject safety, data integrity, and quality.
• Verify the protection of study participants through informed consent procedures and protocol compliance in accordance with regulatory requirements.
• Review CRFs (electronic or paper) and subject source documentation for validity, completeness, and accuracy.
• Verify proper management and accountability of Investigational Product.
• Prepare timely monitoring visit reports, document findings and follow-up actions, update required tracking systems, and escalate issues as appropriate.
• Ensure site documentation is maintained appropriately, support eTMF and ISF compliance, and update CTMS and other required project systems with accurate site information.
Qualifications:
• Bachelor's Degree, preferably in Life Sciences, Nursing, or equivalent.
• Minimum 1 year of relevant clinical research experience or relevant academic background related to clinical trials or clinical development activities.
• Understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Strong written and verbal communication skills with fluency in English.
• Excellent organizational skills and ability to work independently as well as within a matrix team environment.
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You'll 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 30 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 600 professionals, TFS delivers tailored clinical research services in more than 50 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.