Are you an experienced, trilingual freelance CRA with a high interest in Oncology? Are you up for a new challenge in a growing company? This opportunity may be what you are looking for !
The Clinical Research Associate performs site management and monitoring activities within the Site Management department of Clinical Trial Operations.
The CRA monitors site performance and acts as the main line of communication between the participating sites and the LCRA/PM.
The therapeutic area is Oncology and sites to be monitored are in the Flemish and French part of Belgium.
- Perform initiation visits to train and instruct site staff on the study specific requirements
- Assist in site activation
- Perform Monitoring visits to: verify that source data and study database are accurate, complete and maintained properly, verify subject eligibility, verify protocol compliance, including safety reporting and drug handling, verify all study files are maintained and up to date, 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
- 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
- Assure good communication and relationships with (future) clients
- Contribute and take part in client evaluations, visits and bid defenses
- Contribute to other areas of business as required
- Contribute to internal and external audits
- Life science, healthcare, medicine and/or related degree
- Minimum 1-2 year of CRA experience
- Minimum 1-2 years of experience in drug development and/or clinical research
- Good knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
- Good understanding of site management and monitoring
- The ability to perform site visits in an effective way and according to high quality standards
- Strong written and verbal communication skills including good command of English language
- Trilingual (Dutch, French, English)
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence with attention to detail and accuracy
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required
- Strong organizational skills
- A balanced salary package based on your capabilities and experience, including extra legal benefits
- Full time position
- Home Based (European HQ office in Schiphol)
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17599