For one of our clients located in Gembloux, leader in micro-immunotherapy, we are looking for a Clinical Research Associate !
Are you passionate about Clinical Research?
Do you believe that the clinical research should be adapted to each study?
Do you want to join a company with exciting challenges and friendly colleagues?
Then come and work with us to make tomorrow a better place!
Our client is the leader in micro-immunotherapy, a novel immunomodulation therapy using low-dose and ultra-low-doses of immunocompetent substances such as cytokines to tackle diseases resulting from an imbalance of the immune system, both acute and chronic.
The company benefits from the homeopathic regulatory framework and even though most of our studies are double-blind, placebo control studies, we benefit from more creative options when developing our clinical studies.
● You will ensure the management and follow-up of clinical sites in collaboration with the Clinical Project Managers.
● You are responsible to select, initiate new sites and close some others, all in collaboration with the Clinical Project Managers.
● You participate in the preparation and / or review of clinical documents (ICFs, monitoring guidelines…).
● You will prepare the dossiers for the submission to Ethics Committees (EC).
● Serving as a primary contact for investigators, you will ensure ongoing clinical site training.
● Throughout the study, you will monitor ongoing studies, ensuring quality of the collected data in accordance with clinical trial protocols, procedures and ICH-GCPs, write visit reports and manage data queries.
● You will manage payments to clinical sites and verify accuracy of documentation of clinical sites' files.
● Scientific or Health related degree or equivalent.
● Clinical research experience in monitoring is an asset.
● Excellent planning/organizational skills and ability to prioritize and multitask.
● Ability to work in a team as well as independently is required.
● Excellent attention to detail.
● Good verbal and written communication skills in English, French and Dutch.
● Computer Literacy.
● Willing to travel nationally (travel to clinical study sites in Wallonia, Brussels or Flanders).
● Existing right to work in Europe required
Vacancy number : 20002