Senior Clinical Research Associate
New
P
ProPharmaLife Sciences
United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- > 5years of experience as a Clinical Research Associate.
- Required Skills
- GCPMicrosoft Office
Requirements
- Bachelor's degree or equivalent combination of education and experience.
- Minimum 5+ years of experience as a Clinical Research Associate.
- Experience with Electronic Data Capture (EDC) systems.
- Experience with CTMS, IVRS, and eTMF platforms.
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Strong knowledge of local laws, regulatory requirements, ICH Guidelines, and GCPs.
- Excellent verbal and written communication skills.
- Strong organizational skills and attention to detail.
- Ability to prioritize tasks and work with minimal supervision.
Responsibilities
- Perform all types of monitoring and co-monitoring visits including site initiation, interim, and close-out activities.
- Write monitoring reports in accordance with SOPs and local regulatory requirements.
- Manage and train site personnel on protocol requirements, source documentation, and case report completion.
- Review source documents and case report forms for data accuracy, completeness, and integrity.
- Monitor trial activities including site enrollment, protocol deviations, serious adverse events, and laboratory abnormalities.
- Review and oversee regulatory documentation for accuracy and compliance.
- Coordinate with clinical sites, investigators, and cross-functional team members to address study needs.
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