Our client is a CRO formed in 2019 by the merger of two high-performance specialty CROs.
On the one hand known for its ability to design and execute successful development strategies and guide creative new products through the regulatory process and one the other hand recognized for delivering a complete range of clinical trial services and providing strategic consulting to companies developing anticancer drugs.
Now, as a fully integrated global company, the company delivers innovative strategies and robust solutions based on over 30 years of background in regulatory insight, therapeutic experience, and operational expertise.
The company is active in North America and Europe and is developing their activities mainly in biotech and early phase trials. In their current expansion, they are looking for a CRA to perform site management and monitoring activities in Belgium.
- Perform initiation visits to train and instruct site staff on the study specific requirements
- Assist in site activation
- Perform Monitoring visits to:
o verify that source data and study database are accurate, complete and maintained properly
o verify subject eligibility
o verify protocol compliance, including safety reporting and drug handling
o verify all study files are maintained and up to date
o support site staff in preparation for study specific site audits and inspections
- Perform Close-out visits
- Perform Pre-study visits, if delegated by SSU
- Perform centralized and risk based monitoring activities
- Act as the main line of communication between the study PM/LCRA and the site staff
- Maintain study related trackers
- Prepare site visit reports
- Liaise with site staff to achieve patient recruitment targets
- Contribute to the development of study specific documents
- Support the study start-up team in preparation of the submission packages and collection of site documents, if delegated by SSU
Management, Learning & Development:
Actively support site management staff learning & development within the company
Draft and contribute as Subject Matter Expert (SME) in the field of Site Management activities to the evaluation/improvement of processes and procedures within the Quality Management System
Account Management, Sales & Acquisition:
- Assure good communication and relationships with (future) clients
- Contribute and take part in client evaluations, visits and bid defenses
Qualifications and skills
- Minimum 1-2 year of CRA experience
- Knowledge of ICH-GCP
- Good understanding of site management and monitoring
- Strong written and verbal communication skills including good command of Dutch and/or French and English
- Outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Strong organizational skills
Want to take this challenge?