Research Specialist supporting research and evaluation activities for the Health Affairs Institute at WVU. Collaborating with external partners for data collection, analysis, and reporting.
About the role
- Clinical Research Associate overseeing clinical investigations in compliance with regulatory requirements. Responsibilities include document preparation, communication with sites, and data monitoring.
Responsibilities
- Prepare documents required for IRB’s/Ethical Committees submission.
- Develop and write clinical trial protocols, design Case Report Forms, Patient and Investigator Brochure, Informed Consent Form, etc.
- Assist and review interim and annual study reports and response for FDA.
- Communicate with Investigative Sites and consultants on conducting clinical trials.
- Data compilation, ensuring quality control and compliance with protocol and provide initial analysis of results.
- Monitor clinical trial progress through a combination of data review and on-site monitoring visits.
- Conduct site visits for pre-qualification, qualification, initiation, monitoring and close-out.
- Verify that data entered on to the CRFs is consistent with patient clinical notes.
- Discuss study results with a biostatistician for clinical trial reports.
- Archive study documentation and correspondence and prepare final reports.
- Provide clinical support to Quality Affairs in the analysis of clinical complaints and FMEA.
- Provide clinical support to Regulatory Affairs in the creation of documents required for products registration and technical file.
- Create, implement, and administer methods and procedures to enhance operations, as appropriate.
- Stay up to date on ethical considerations, scientific principles, legislation and regulatory guidelines and requirements related to Clinical Evaluation Report and Clinical Trials.
Requirements
- Bachelor’s degree in health, life science, or other relevant field of study
- Advanced English C1
- 2+ years of experience on similar roles
- Knowledge of GCP/ICH guidelines
- Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.)
- This role requires periodic travel to the United States and other regions.
Benefits
- A valid U.S. visa and full travel availability
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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