(Senior) CRA

Job description

The Senior Clinical Research Associate (CRA) will strengthen our team within Clinical Operations Department, supporting our many projects. As an experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field of clinical research, you will be a productive member of the team. You enjoy start up, enrollment, follow up and closure of clinical trial activities, and mainly monitoring the progress of clinical studies at the site level.

Responsibilities

ₒ Clinical Site Start-up:

  • Support with identification of clinical sites
  • Preparation of packages for ethical committee (EC) submissions
  • Submissions to ECs
  • Preparation of site budget, negotiations of site budget
  • Organization, preparation, performance, follow-up of Site Qualification visits, Site Initiation visits

ₒ Clinical Site Management:

  • Organization, performance, follow-up of trainings
  • Organization, preparation, performance, follow-up of Monitoring visits, Close-out visits
  • Identification, communication, resolution of site-related matters, issue escalation
  • Site leadership

ₒ Development, writing, review of task-related SOPs

ₒ Support clinical supply chain

Profile
  • Bachelor or Master degree in (para-) medical or scientific field
  • Involvement in study start-up and EC submissions in at least 2 countries
  • At least 7 years of clinical research experience including monitoring, or in pharmaceutical data management including activities during data base locks, or as a study coordinator
  • Experience with oncology in early phases
  • Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage

Skills & Competencies:

  • Very strong attention to details
  • Work precisely as per procedures, rules and regulations
  • Objective and analytical
  • Planning & Organizing skills
  • Team spirit
  • Excellent English, French and Dutch knowledge (“trilingual”, oral and written), additional languages are an asset
  • Strong communication skills
  • Hands-on attitude
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including a company car, medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Location
Mont-Saint-Guibert
Contact person

Tim Janssen

Personal profile
Attachments
PDF, DOC, DOCX (5MB)
Contact details
Evelien
Van Eecke
Recruitment Specialist

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 476 98 62 94
evelien.vaneecke@fern-valley.com