Perform clinical research site assessment to evaluate the expected performance level for a specific protocol (e.g. medical expertise, facilities, compliance and enrollment rate).
Be an efficient communication link between the European clinical research department and the clinical research centers.
Developing/maintaining relationships with Key Opinion Leaders (KOL).
Collect essential documents for clinical research site.
Work with site and local Regulatory Affairs representative (if applicable) to prepare Ethic Committee submission and obtain approval(s).
Follow Competent Authority notification and submission (with PM and local Regulatory Affair representative or local clinical research department).
Site Initiation for clinical Studies in compliance with company SOPs, ISO 14155, monitoring plan and applicable local and international regulations.
Organize and perform site training on all aspects of the respective clinical study, including clinical investigational plan, informed consent process, investigational device, A(D)E/SA(D)E reporting, handling of deviations and study procedures including (e)-CRF, compliance, randomization service and other applications if applicable.
Address site authorization process and investigator responsibilities.
Conduct Interim Monitoring of clinical trials in compliance with company SOPs, ISO 14155, monitoring plan and applicable local and international regulations.
Review progress of the trial and report.
Source data verification (compare original patient data to CRF entries).
CIP compliance and deviation handling.
Inventory control (where applicable).
CRF completion and adherence to data collection guidelines.
Subject recruitment process and consenting process.
Review study documentation and retention.
Staff changes, if yes, supply additional training.
Follow up of action items and corrective actions.
Reporting to ethical committee of safety and protocol deviations.
Conduct Final Monitoring of clinical trials in compliance with company SOPs, ISO 14155, monitoring plan and applicable local and international regulations.
All unresolved issues must be addressed and the CRF must be complete, accurate, and signed by the Investigator.
All study site documents will be reviewed, filed, and prepared for archiving.
Inventory will be reconciled and removed from the site after patient inclusion has been completed (where applicable).
Coordinate that study material will be returned to Abbott Vascular.
Strong organizational, planning and prioritization skills and can function as part of a Team.
Excellent verbal and written communication skills.
Problem identification and solving skills.
Detail and quality oriented.
Stress management techniques.
Ability to understand and to follow work processes (SOPS, guidelines, protocols) within the assigned function.
Bachelor’s degree with related work experience preferred or an equivalent combination of education and work experience.
Refer to CRA Level Description Matrix for additional requirements.
Fluent in English.
Ability to travel.
Able to work in international environment / Diversity.