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 responsible for coordinating clinical trials and ensuring regulatory compliance. Conducting patient care activities and maintaining data integrity in accordance with study protocols.
Responsibilities
- Identify, screen, randomize, and enroll patients into IRB-approved clinical trial protocols
- Conduct all trial-related procedures in accordance with IRB-approved protocols, Sponsor requirements, SOPs, and Good Clinical Practice (GCP) guidelines
- Perform direct patient care activities including informed consent, physical assessments, blood draws, medication administration, and ECG procedures
- Ensure accurate and timely data entry into Sponsor Electronic Data Capture (EDC) systems and maintain clean, complete study data
- Oversee site initiation activities and support study startup, maintenance, and close-out processes
- Prepare and submit regulatory documentation required for study startup and ongoing trial maintenance
- Maintain and update IRB submissions, amendments, and continuing reviews, resolving regulatory issues promptly
- Create and maintain up-to-date source documentation (paper-based and/or electronic source) for each study
- Review audit findings with the Principal Investigator and Director of Clinical Operations and implement corrective actions as needed
- Identify, document, and report Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and violations accurately and in a timely manner
Requirements
- High school diploma or equivalent required; Bachelor’s or Associate degree preferred
- Minimum of two years of experience coordinating industry-sponsored clinical trials
- At least one year of experience in a medical, hospital, or research setting
- Strong written and verbal communication skills
- Ability to frequently lift up to 15 pounds and occasionally transport up to 25 pounds
- One year of laboratory coordination experience
- RN certification or certification in Phlebotomy and/or IV infusions preferred
- Experience preparing and submitting IRB applications, including new studies and amendments
- Knowledge of regulatory compliance, GCP standards, and Sponsor expectations.
Benefits
- Health & safety protocols for patient-facing employees
- Reasonable accommodations for medical conditions or religious beliefs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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