* Early Stage Clinical Research
* 6-month assignment to start asap
* North of Belgium
Our client, a major player in the pharmaceutical field, is currently looking to reinforce its Clinical Research team with a Senior Clinical Research Associate experienced in conducting phase I studies.
As a Senior Clinical Research Associate, you will perform site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, federal regulations, and SOPs. You will ensure sites meet performance expectations related to recruitment, enrollment, and retention of volunteers. You will maintain ongoing communications with site personnel and assist with problem solving during study conduct. You will review site source documentation, case reports and verify accurate data capture. Performing drug accountability, reconciliation, and destructions are also part of your responsibilities as well as verification that storage and shipment requirements are according to protocol. You will ensure site regulatory files are current, and care for the timely submission of study documentation (including safety reporting). You will identify and record protocol deviations, analyze issues and use sound judgment to make decisions escalating study-related issues as necessary. You will actively participate in team meetings and may lead process improvement initiatives for the department.
For this role, we are looking for a Senior CRA with prior experience in Phase I trials. A working knowledge of the clinical drug development process as well as ICH, GCP guidelines and US FDA regulations is required. You are a resourceful communicator, familiar with medical terms and able to troubleshoot and solve problems. Excellent written and verbal skills in English and Dutch are essential.
This is a 6-month assignment open for both candidates working on a freelance or employee basis. The role is based in the north of Belgium, but can also be home-based with regular travels required to the north of Belgium for site monitoring.
Interested? Don't hesitate to contact Ms Kateryna Hamandiy, Hays Life Sciences Recruiter, at +32 10 233 866 to get some more information about this role.