Clinical Research Coordinator II

Thermo Fisher Scientific · Atlanta, GA

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Clinical OperationsFull timeCompany career page

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Role summary

Clinical Research Coordinator II to oversee site activities and ensure compliance with FDA/GCP regulations. The role involves conducting clinical studies, managing patient visits, collecting data, and maintaining regulatory documentation while prioritizing patient safety and data integrity.

What they're looking for

Bachelor's degree or equivalent formal academic/vocational qualification
Current BLS certification
2+ years of relevant clinical research or healthcare experience
Solid understanding of GCP, SOPs, informed consent, and safety monitoring
Proficiency with computer applications and electronic data capture systems
Strong attention to detail and ability to work independently
Excellent communication and interpersonal skills

What you'll be doing

Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines
Schedule subject visits, perform screening, informed consent, and protocol procedures including vital signs and ECGs
Record patient information and test results on required forms and electronic systems within specified timeframes
Ensure IRB approval and compliance throughout the study; report suspected non-compliance to site staff
Maintain source documents, update patient files, and manage follow-up calls for patient retention and bookings

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Date posted2 days ago

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