Clinical Research Associate

Job description

The Clinical Research Associate will manage clinical trial sites at every stage of the clinical trial process to a high quality in accordance with the Company’s policies and procedures, relevant legislation and ICH GCP requirements.

Responsibilities
  • Work within the respective country with one or more clinical trials, representing the local team in the CDC trial team led by the CDC Trial Manager, when applicable.
  • Primary point of contact between site staff and the company, act as an ambassador and contributes to making the company the preferred partner in clinical trials.
  • Contribute to or lead selection of sites, in collaboration with CDC and local colleagues such as LM and Medical Affairs.
  • Overall site management, including site monitoring and remote monitoring as applicable.
  • Ensure that trial site staff are properly trained to conduct the trial(s), provide necessary training and identify and flag any development areas and implement mitigations.
  • Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme.
  • Close collaboration with relevant roles to ensure successful conduct of the trial, such as local Lead CRA, CDC Trial Manager, CDC CTA and local Line Manager
  • Ownership of site management and trial conduct and timely flagging of any issues proactively to relevant roles within local team and/or CDC.
  • Agree on tasks responsibility split and timelines with CDC CTA within the trial, including timely provision of trial documentation.
  • Contribute to or drive Scientific Recruitment and Retention (SRR) planning and execution, in collaboration with CDC Trial Manager and as agreed with Line Manager.
  • Perform local administrative tasks as agreed with the Line Manager.
  • Responsible for site preparedness for audits and inspections and all related follow-up activities.
  • Other relevant trial, site or documentation related tasks as assigned by line manager.

Profile

Qualifications:

  • Bachelor's Degree level, life science or nursing qualification or equivalent (desirable)
  • Basic GCP qualification
  • Very good knowledge of French and English

Technical Skills:

  • Knowledge of clinical trial methodology
  • Knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs
  • Knowledge of drug development process
  • Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF
  • Computer literacy and IT skills

Work experience

  • Healthcare industry experience or customer service based employment
  • Previous experience of monitoring trials in accordance with ICH GCP methodology
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
Brussel
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