Thermo fisher scientific
Clinical Research Associate
Overview
Perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or onsite monitoring visits to assess regulatory compliance and manage required documentation.
About Thermo fisher scientific
Join us as a Clinical Research Associate II/Sr. Clinical Research Associate I- Make an impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
Requirements & Eligibility
- Bachelor's a life sciences related field or a Registered Nurse Certification or equivalent and relevant formal academic/vocational qualification
- Minimum of 1 year of oncology monitoring experience, OR minimum of 2 years of standard monitoring experience with relevant prior clinical experience (e.g., MD, RN, Study Coordinator)
Key Responsibilities
- Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into c
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Participates in investigator meetings as necessary and identifies potential investigators in collaboration with the client company.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
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