Clinical Research Associate - Freelance
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AI Summary
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 [0.5-0.8 FTE] based in the Netherlands.
Please, keep in mind that this is a part-time role directed at freelance professionals only.
About this role
As part of our CDS Internal Medicine and Neuroscience team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Clinical Research Associate is responsible for the initiation, on–site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other 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 regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
Verify proper management and accountability of Investigational Product.
Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
Update CTMS and all other required by projects systems with accurate site level information
Qualifications:
Bachelor’s Degree, preferably in life science or nursing; or equivalent
Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities
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.
Experience with cardiovascular studies with Medical Devices is a big plus.
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.
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