Clinical Research Associate
hace 13 horas
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. This strategic partnership enables us to deliver tailored clinical research services in over 40 countries across key therapeutic areas such as Dermatology, Neuroscience, Oncology, and Ophthalmology.
The Clinical Research Associate - Site Monitoring Specialist will be responsible for ensuring our customers achieve their goals by working alongside passionate and innovative professionals. This role involves conducting on-site and remote monitoring of investigative sites during study conduct, according to company policies, SOPs, and regulatory requirements.
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.
The ideal candidate will possess a Bachelor's Degree, preferably in life science or nursing, with a minimum of 1-3 years of relevant clinical experience. They will also have the ability to work in a fast-paced environment with changing priorities and understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
What We OfferWe provide a competitive salary of $60,000 - $80,000 per year, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. As a valued member of our team, you will contribute to the completion of applications to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements, and participate in contract handling and negotiation directed by Lead CRA/Project Manager.
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