Clinical Research Coordinator - Belgium
Want to know company name or location? Company managed [?]
Posted on : 15 April 2017
As Clinical Research Coordinator, your main responsibility is the preparation, realization and coordination of clinical phase I, II and III trials that are conducted in or with the CPU Unit, under the supervision of the Principal Investigator.
You ensure an efficient preparation of the trial.
- 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,...).