Clinical Development Specialist

4 giorni fa

Montà, Italia Buscojobs España A tempo pieno

About us at TFS Health Science, a global Contract Research Organization (CRO), we partner 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 Research Associate role is part of Strategic Resourcing Solutions (SRS) within our organization and functions operationally as a member of a Project Team. The successful candidate will be 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, 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, 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 the Monitoring Visit Report, including findings, corrective and preventive actions already taken, and updating applicable tracking systems.
  • Evaluate site performance and provide feedback for improvement.

Qualifications:

  • Bachelor's Degree, preferably in life science or nursing or equivalent.
  • Over 4-5 years of relevant clinical experience or relevant academic background around clinical trial or clinical development activities.

We offer a competitive compensation package estimated at approximately €60,000 - €80,000 per year, 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.

About Us:

TFS Health Science has been delivering 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 decision-making at all levels of the organization.

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