Senior Clinical Research Associate Specialist
hace 3 días
Tfs Healthscience is a leading global 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.
Job DescriptionWe are seeking an experienced Clinical Research Associate to join our Strategic Resourcing Solutions (SRS) team. As a member of this team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.
Key Responsibilities:- Monitor on-site and remotely clinical trials in accordance with Tfs Healthscience and/or client company Standard Operating Procedures, FDA regulations, and Good Clinical Practice (GCP) guidelines.
- Review Case Report Forms (CRFs) 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 them 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/Institutional Review Board (IRB), prepare necessary documentation enclosed to the application according to local requirements in cooperation with Clinical Trial Associate (CTA) and directed by Lead CRA/Project Manager.
- 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.
We provide a competitive salary range of $70,000 - $90,000 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.
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