Clinical Research Associate
hace 16 horas
About TFS HealthScience
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.
Job Description
We are seeking a skilled 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.
The successful candidate will be 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.
Key Responsibilities:
- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company standards, 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 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/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager.
- Participate in contract handling and negotiation 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.
Salary and Benefits
We offer a competitive compensation package, estimated at around $80,000 - $100,000 per year, depending on experience, plus comprehensive benefits and opportunities for personal and professional growth in a rewarding environment.
Our Team
You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients. Our journey began over 27 years ago in Sweden, in the city of Lund. We build solution-driven teams working towards a healthier future, 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.
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