To match our clients' demands, we are actively looking for 2 profiles of CRA - juniors, and experts, from 2 years to 8+ years of relevant experience.
- Do you have a University Degree in Life Sciences?
- Do you have a first experience as a CRA or as a Study Coordinator?
- Are you fluent in English - any other EU language are assets?
Then, our thrilling offer is the next step in your professional path!
As CRA, you perform on-site monitoring visits, either nationally or internationally - within EU countries.
You use your expertise to build and maintain the site relationship and ensure they are set up for success.
This includes addressing and resolving site issues and questions.
You also manage site quality and delivery from site identification through to close-out.
It means that you ensure the clinical trial is conducted, recorded and reported in accordance with the protocol, the principles of Good Clinical Practice (GCP) and the applicable regulatory requirements.
- You act as the company’s sole contact with assigned clinical sites
- Depending on your level of expertise, you conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites. You generate a visit/contact report
- Depending on your level of expertise, you review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with the protocol
- You perform on-site monitoring visits according to the monitoring plan and following the company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines
- You ensure and control sites’ compliance with the study protocol and regulatory obligations
- You evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
- You address issues in a manner that is beneficial for the site and the team
- You report the findings of the “on-site” monitoring visits according to the company's Standards
- You follow the sites’ findings until resolution, with the support of the study team and Quality Assurance and Control unit
- You perform site staff training whenever needed during the study conduct
- You ensure close collaboration between all actors of clinical trial research, as a privileged link between investigational sites and the study team
- You have a University Degree in Life Sciences
- You have a first relevant experience as a CRA or as a Study Coordinator
- You have practical knowledge of the conduct of clinical trials
- A strong understanding of clinical trials methodology and terminology is mandatory for the Senior position
- Previous experience in oncology is an advantage for the Junior position
- You are fluent in English (written & spoken). Any other EU language are assets (French, Dutch, German, Italian, Spanish)
- You have a problem-solving nature
- You have excellent organization skills
- You are good at multitasking, able to evaluate a variety of unpredictable scenarios and achieve project timelines
- You have good communication skills
- You are proactive and dynamic
- You are independent and team-player