Senior CRC (Stuivenberg) ()

Beschrijving:

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 in Antwerp, under the supervision of the Principal Investigator. – You ensure an efficient preparation of the trial. o Coordinate volunteer recruitment and ensure procedures for screening and enrollment o Ensure the availabitliy of CPU staff on the project – You plan, coordinate and manage the trial protocol o Prepare general study schedules in LabPas o Develop study specific instructions and manuals o Perform clinical activities where appropriate o Ensure periodic and ad hoc reporting to investigators, administrative staff, agencies, regulatory authorities o Cooperate with external monitors, internal QC teams and QA to ensure compliance with protocol, SOP’s, regulations and guidelines. – You oversee day to day execution and progress of the clinical trial activities and ensure quality o You ensure periodic and ad hoc reporting to investigators, administrative staff, agencies and regulatory authorities o You 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, lab technicians, nurses, pharmacist, recruitment officers, clinical project managers) and towards sponsors and vendors. – You ensure the provision of support services to the internal/external investigators. – You participate in an “on duty” system. – You contribute proactively to team and staff meetings. As a senior CRC: – You also provide leadership and coaching to junior clinical research coordinators and other CPU personnel. – You ensure periodic quality reporting to CPU, SGS internal project and BD teams – You participate in budget creation, revision and reconciliation processes and manage activities of studies within the defined budget. – 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 may act as back-up for the team leader of CRC. 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 as clinical research coordinator or senior clinical research associate. – 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,…). A challenging and responsible function within a challenging scientific world ! SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 75 000 people and operates a network of more than 1 000 offices and laboratories around the world. In Belgium 1.650 people are working for SGS. One of the business segments, SGS Life Science Services, is a leading contract research organization (CRO) offering Clinical Research and Quality Control/Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product. We are looking for a: Senior CRC (Stuivenberg hospital Antwerp) Please apply online via: www.be.sgs.com/Careers. Should you have further questions, please contact us on [email protected].

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