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.

Clinical Research Associate

Key skills