- Coordinate volunteer recruitment, and ensure procedures for screening and enrollment
- Ensure the availability of CPU staff on the project
- You plan, coordinate and manage the trial protocol
- Prepare general study schedules and subject specific treatment schedules
- Create study schedule in LabPas
- Develop study specific instructions and manuals
- You perform clinical activities where appropriate
- Ensure periodic and ad hoc reporting to investigators, administrative staff, agencies, regulatory authorities
- Cooperate with external monitors, internal QC teams and QA to ensure compliance with protocol, SOPs and regulations and guidelines.
- You are the primary administrative site-contact for internal CPU staff (investigators, Labo, Nurses, Pharmacy, recruitment, Clinical Project Managers, and towards sponsor and vendors.
- You ensure the provision of support services to the internal/external investigators
- You demonstrate a positive and proactive attitude towards continuous management of quality, creation and follow-up on corrective measurements, participation to and follow up of audits
- You work in a multidisciplinary team of investigator, nursing staff, project manager, laboratory technician, pharmacist, recruitment officers and administrative staff.
- Nursing, paramedical or scientific (university) background, with additional relevant experience within clinical research
- Strong organisational and presentation skills
- Customer minded
- Strong communication skills, flexible, quality minded and stress resistant
- Team player, problem solver, able to guide team within tight deadlines
- Fluent in Dutch and English (written and oral)
- Proficient in general software applications (Excel, Word,...).