Clinical Research Associate II (J & J Brussels)

Overview: This individual will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group.

Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between Clinical Operations and study site personnel for the specific clinical projects.

Benefits
• Uitdagende projecten in lijn met jouw interesses en talenten
• Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
• Mogelijkheid tot het volgen van extra opleidingen
• Inspirerende netwerkevents... en legendarische afterwork drinks
• Sterk netwerk van toonaangevende klanten
• Expertise binnen IT, Engineering en Life Sciences
• Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors
• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
• Un package salarial attractif avec de nombreux avantages extra-légaux
• Un suivi clair et personnalisé, une communication transparente autant durant la période de recrutement qu’une fois l’entrée effective en poste
• La possibilité de suivre des formations
• Divers événement vous permettant de développer votre réseau et des afterwork drinks légendaires
• Un réseau puissant de clients, leaders dans leur domaine
• Une expertise dans les domaines de l’informatique, de l’ingénierie et des sciences de la vie
• Un tremplin vers une évolution rapide pour les juniors et la possibilité de partager des connaissances acquises pour nos employés plus seniors

Have you got what it takes?

Key Job Activities: Clinical Study Site Management Tasks
• Ensures that all work-related activities, and decisions embody the Johnson & Johnson Credo Values.
• Verify safety and well being of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices, and regulatory requirements.
• Accountable for study site performance and providing high quality data according to overall project timeline.
• Assist Clinical Operations staff and study site staff to resolve issues quickly and effectively. Responds to problems and assists in implementing corrective and preventive actions, if required.
• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
• Responsible for supporting patient recruitment and retention activities.
• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies, and procedures.
• Assists with internal communication of important clinical data and events.
• Support organization of Investigator and other study training meetings, if required.
• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• May be involved in other tasks to support Clinical Operations and Operating Company as needed.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.

Administrative Tasks
• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and
Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.
Education
• A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
Experience
• Typically requires bachelor’s degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.
• Previous clinical research experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background - a plus.
Knowledge
• Requires experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and Power Point).
Additional Requirements
• Demonstrated competencies in the following areas are required:
• Leadership
• Written and verbal communications
• Presentation and influencing
• Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).
• Ability to travel up to 80% of time.
• Full driving license.
• Fluent in Dutch and English
Belgium

Salary Criteria