Senior Clinical Research Associate
Indexed description
Responsibilities of the Senior Clinical Research Associate include:
- Conduct site monitoring visits to ensure compliance with GCP, ICH, and regulatory guidelines
- Support subject recruitment and adapt recruitment plans as needed
- Provide protocol training and manage communication with study sites
- Assess site adherence to protocol and regulatory requirements, reporting quality issues
- Track study progress, including regulatory approvals, enrollment, data collection, and query resolution
- Minimum 2 years of recent on-site monitoring experience within Oncology
- Proficiency in CTMS, EDC, and Microsoft Office Suite
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements
- Experience in site management, patient recruitment, and clinical trial documentation
- Bachelor’s degree in life sciences, nursing, or a related field (advanced degree preferred)
Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
This job opens for applications on 8/31/26. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: clinical research, clinical trials, GCP, regulatory compliance, clinical monitoring, data collection, site management, protocol adherence, patient recruitment, adverse event reporting, clinical study, documentation, IRB submissions, clinical trial management, data analysis, quality assurance, clinical operations, SOP, FDA regulations, ICH guidelines, electronic data capture, clinical trial design, risk management, stakeholder management, project management, communication skills, collaboration, oncology, biostatistics, clinical data management, regulatory submissions, clinical research ethics, clinical study reports, budgeting, contract negotiation, time management, decision making, clinical trial protocols, molecular biology techniques, cell culture.
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