Clinical Research Associate (Oncology)

Job description

The Clinical Research Associate is responsible for the management of investigator sites throughout the site lifecycle, whilst working in accordance with ISO14155 guidelines, the study protocol, applicable regulatory requirements and SOPs.

Responsibilities

Preparation of Clinical Trials

  • Site assessments preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patients information,...)
  • Preparation of files for the submission to Ethical committee, Competent Authority and other bodies if needed
  • Preparation and management of Clinical trial documentation
  • Follow-up of agreements with hospitals and investigators
  • Technical preparation of Investigators and Steering Meetings
  • Check the status of patient enrolment and milestone follow-ups in hospitals and feedback the status to investigators and study management periodically
  • Clinical trials monitoring
  • Provide assistance to global Clinical and Regulatory personnel
  • Assistance in audit preparation

Regulatory

  • Be compliant with the regulations related to the conduct of Clinical Trials according to international guidelines, local regulations and center specific requirements

Clinical Trial Monitoring

  • Perform feasibility visits
  • Perform site initiation, FUP and close-out visits
  • Source data verification on-line and on-site
  • Verification of inconsistencies on the case report forms
  • Source documentation request
  • Data cleaning (including but not limited to queries formulation and resolution)
  • Preparation of presentations
  • Preparation of Newsletters
Profile
  • Master Life-science degree or equivalent by experience
  • Experience as a CRA is a must, with a first experience in Oncology studies (pharma or devices)
  • Experience in medical devices is an asset
  • Must be able to work in an international environment
  • Fluent in English and preferably one other European language
  • Ability to function in a self-directed manner with a high degree of independence
  • Flexibility to travel 20% of your time across Europe
  • You work minimum 3 days/week in the office in Leuven
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
Leuven
Contact person

Tim Janssen

Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
Managing Partner

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

+32 487 10 61 46
tim.janssen@fern-valley.com