As a Clinical Research Associate your role is for example:
Organization of all types of site visits including Site Selection, Initiation, Monitoring, and Close-out;
Responsibility of the drug accountability and other monitor activities to assure adherence to Good Clinical Practices (ICH GCP), SOPs, and study protocols;
Ensuring the availability of selected study centres, adequate qualification resources, suitable volunteers and qualified examiner;
Monitoring of clinical trials including the trial-specific monitoring plan and compliance with regulations, ICH/GCP guidelines and IRB approvals;
Responsibility for various documents and approvals such as submissions/notifications to national health authorities, submissions to IRB/Ethics Committees, AE/SAE expertise, updates, protocol changes, safety reports;
Working with the Regulatory Division for timely results;
Contact person for the clinical sites and reporting to the study director.
That is your Candidate Profile
Bachelor’s degree, preferably in biomedical sciences or related scientific discipline;
Prefer a minimum of 4 years monitoring experience;
Thorough Knowledge of FDA regulations and ICH/GCP guidelines;
Ability to travel up to 80% depending on project;
Very good skills in MS-Office;
Fluent knowledge of the local language and very good knowledge of English.