Global Clinical Research Associate

1 semana atrás


Porto, Porto, Portugal Tfs Healthscience Tempo inteiro

Our company, TFS HealthScience, is a leading Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to facilitate their entire clinical development journey. With expertise in full service-capabilities, resourcing, and Functional Service (FSP) solutions, we are well-positioned to support our clients' goals.

The role of Clinical Research Associate (CRA) 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. The CRA may conduct all stages of site monitoring, including feasibility, pre-study, initiation, interim, and close-out. This position requires ability to travel as needed, which may involve overnight and international travel.

Key Responsibilities:
  • Monitor on-site 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.
  • Initiate 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.
Qualifications:
  • Bachelor's Degree, preferably in life science or nursing or equivalent.
  • Minimum 1-3 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, estimated to be around $80,000 per annum, depending on qualifications and experience.
  • Comprehensive benefits, including health insurance, retirement plan, and paid time off.
  • The opportunity for personal and professional growth in a rewarding environment.

TFS HealthScience has over 27 years of experience in providing tailored clinical research services in more than 40 countries. Our team of over 800 professionals is dedicated to delivering high-quality solutions across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology. We value collaboration, innovation, and making a difference in the lives of patients.


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