Clinical Research Associate
Il y a 5 mois
The Clinical Research Associate (CRA) works under the hierarchical supervision of the Head of Monitoring.
Main responsibilities / Major Activities
The CRA is responsible for “on-site” monitoring of clinical trials to ensure that it is conducted, recorded and reported in accordance with the protocol, the principles of Good Clinical Practice (GCP) and the applicable regulatory requirements. Clinical monitoring is integrated into a multi-step process involving close cooperation between the participating investigators, research nurses, and other site scientists involved in the clinical trial.
Perform on-site monitoring visits to EORTC participating institutions according to the monitoring plan and following the EORTC Standard Operating Procedures (SOPs) and GCP guidelines.
Ensures and controls sites’ compliance with the study protocol and associated guidelines
Address issues in a manner that is beneficial for the site and the EORTC team
Support the site’s staff to reach a better quality level, as needed
Report the findings of the on-site monitoring visits according to EORTC Standards
Follow the sites’ findings until resolution with the support of EORTC study team and Monitoring department staff, as appropriate.
Perform site training before and/or during the study conduct, as required
Ensures close collaboration between all actors of clinical trial research.
Profile
University degree or equivalent in Health Sciences
Prior experience in Oncology
Good verbal and written communication skills
Excellent organization skills
Proactivity and dynamism
Flexibility with respect to work assignments and new learnings
Ability to travel 40% of working time across European countries.
**Languages**: English (written & spoken) is mandatory.
**Other language(s) of interest**: Dutch, French, Spanish
**Benefits**:
Permanent contract
Wage according to our Non-Profit organisation status
Hybrid working environment (from Belgium only)
30 days holidays (full time)
Meal vouchers
Pension plan
Hospitalisation insurance and ambulatory care
Homeworking allowance
Reimbursement of public transport
Free parking
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