Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
About the role
- Clinical Research Coordinator I managing clinical trial screenings and data collection for pharmaceutical studies. Overseeing participant enrollment and ensuring compliance with regulatory guidelines.
Responsibilities
- Responsible for calling potential candidates that pre-qualify for clinical research to schedule a screening visit
- Perform all clinical trial activities and assessments, as allowable per ICH and FDA regulatory guidelines
- Collect vital signs, provide surveys to the clinical trial subject, perform assessments per the protocol
- Meet with monitors and sponsors to review accuracy of data collected
- Help stock the clinical research center with necessary clinical trial supplies
- Ensure all equipment in the clinical research center and laboratory is appropriate for clinical trial general use
- Ensure temp probes in the clinical research center are working properly
- Contribute to the regulatory binder by providing necessary forms requested to ensure compliance
Requirements
- Bachelor's degree
- Four years of direct experience for a bachelor’s degree
- Human subjects protections training
- Knowledge of the Code of Federal Regulations
- GCP (Global Good Clinical Practice)
- ICH (International Council for Harmonization) Guidelines as applied to clinical trials
- IRB and other regulatory processes and procedures including HIPAA
- Shipping biohazard materials certification preferred
- Current certification in clinical research is preferred
- Strong working knowledge in Microsoft Office programs and other software packages
- Medical and research terminology, processes and procedures, phlebotomy experience, ECG training and training in other clinical procedures, and general knowledge of infection control procedures
Benefits
- Medical, dental and life insurance plans
- Retirement plan options
- Employee and dependent tuition programs
- Generous leave
- Hundreds of employee perks and discounts
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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