Clinical Research Consultant (CRC)

Task description

Site Management

  • assume on-site monitoring duties and quality audits as needed
  • oversee investigator recruitment, qualification and selection
  • coordinate inventory and shipment of investigational products, clinical supplies and documents
  • overlook patient enrollment and identify/outline patient recruitment strategies
  • assure timely reporting of AEs/SAEs
  • report appropriately Protocol Violations/Deviations
  • assure compliance with ICH and GCP guidelines , CFR and State regulations, Sponsor and KasaConsult SOPs

Data Handling

  • perform source document verification according to contractual requirements
  • assure timely completion and submission of CRFs according to Clinical Monitoring Plan and/or Data Managing Plan
  • assure timely and accurate completion of Data Clarification Forms

Reporting and Tracking

  • complete and submit visit trip reports
  • maintain awareness of key study performance indicators
  • update study and patient status information and serve as resource
  • track investigator payments
    - document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit.</il>

Regulatory Submissions and Documentation

  • perform or assist with submission of clinical trial dossiers and documents to Competent Authorities (CA) and Ethics Commitees (EC)
  • understand the EC/CA submission process in Belgium, The Netherlands and France
  • maintain current regulatory documentation


  • maintain timely and effective communication among team members and site staff
  • assure timely and detailed feedback to sponsor
  • organize and present on project and investigator meetings


  • excellent in social and interpersonal contacts
  • able to handle multiple tasks to meet deadlines
  • motivating people (coaching, counseling, mentoring)
  • customer-oriented, enthousiastic, dynamic
  • willing to travel

Education, knowledge and experience

  • Msc Biomedical Sciences, Msc (Para) Medical Sciences, or equivalent by experience
  • minimum 1-2 year of experience in a similar function and/or in a CRO,in the pharmaceutical/medical device, in the biotechnology sector
  • excellent in Dutch, French and English (spoken as well as written)
  • experience in Microsoft

Our offer

KasaConsult offers you a challenging job with an interesting salary and extralegal benefits within a pleasant work atmosphere and on a location without traffic jams.

Possibility of development of your personal skills via courses.

Please send your reaction preferably by e-mail to k.seldeslagh(at)