Clinical Research Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Clinical Research Specialist to join our contingent workforce. You will be working in the CNV Clinical Team of J&J in Diegem, Belgium. This will be an initial contract opportunity, starting asap until December 31st 2022.

This is an off site/ on site position with minimum 1 day/week to preferable 2-3 days/week on site in Diegem, Belgium.

Also, travelling across Europe (Spain, Italy, France, Germany, UK) is part of this position on frequent basis. 

Project Scope:

• The Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Your Responsibilities:

• Participate in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
• May serve as the primary contact for clinical trial sites (e.g. site management)
• Assist in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
• Coordination and execution of ordering, tracking, and managing investigational products and trial materials
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
• Assist in overseeing the development and execution of Investigator agreements and trial payments
• Assist in clinical data review to prepare data for statistical analyses and publications
• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• Assist in tracking assigned project budgets
• Develop a strong understanding of the pipeline, product portfolio and business needs
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple situations but required guidance for complex situations

Minimum requirements: 

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
• Previous experience in clinical research or equivalent is desired.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background a plus.
• Medical device experience a plus.
• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations
• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations
• Presentation and technical writing skills
• Connect - Develop collaborative relationships with key internal and external stakeholders.
• Shape - Actively participate in departmental process improvement activities.
• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

If you meet our requirements and are interested in hearing more about our Clinical Research Specialist role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!