The Clinical Pharmacology Unit is attached to Janssen Pharmaceutica N.V. The unit, located at the Jan Palfijn Hospital in Merksem, is responsible for the execution of the clinical pharmaceutical research on healthy volunteers. Contact us now and discover via Randstad the CPU and the innovative world of clinical research.
As the Flex Laboratory Coordinator you are committed to produce high quality study data in accordance with the unit's Standard Operating Procedures, and in compliance with applicable scientific, ethical and regulatory requirements. You also supervise the group of laboratory technicians of the department. As a part of the study team you participate in the safe and efficient execution of clinical studies for all activities related to the Flex Laboratory. Accordingly you are responsible for the professional management of all operational activities regarding biomarker assay implementation, calibration and validation. Dependent on the qualification and validation processes of the Flex Laboratory, you are leading the activities related to processing & measurement of biomarker samples.
The Flex Laboratory Coordinator represents the Flex laboratory as QC coordinator and is the Deputy of the Flex Laboratory Manager in her/his absence.
- Together with the Flex Laboratory Manager leading the laboratory assessments in CPU's study feasibility procedure
- Executes the tasks and duties of the role as described in departmental SOPs and Working Instructions
- Reviews and provides input to laboratory related parts of study protocols
- Bring scientific content to Flex Lab Team, specifically in biomarkers and biomarker equipment
- Makes sure that study specific critical steps are adequately defined and logged in the workflow and data capture systems of the department
- Supports the high-level planning of trials
- Liaises with the Resource Manager to make sure that sufficient qualified resources are planned for trial execution in the Flex laboratory
- Ensures detailed preparation for trial execution with respect to materials and methods, the preparation of written instructions for Laboratory Technicians, Clinical Research Coordinators (CRCs) and Trial Nurses
- You are a graduated laboratoy technician with a master or PhD in Clinical Chemistry
- You have a minimum of five years relevant working experience in Clinical Chemistry laboratory or phase I unit
- Good working knowledge of the ICH-GCP guidelines and other relevant regulatory guidelines and regulations
- Able to apply technical/professional knowledge to the execution of clinical trials
- You are fluent in Dutch and English (written & spoken)
- You are result driven, pro-active and creative in indentifying and solving problems
- Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to garantee the safety of the volunteers or patients
We offer a permanent placement in an interesting sector.
Are you interested? Contact us on 03-201 87 71 or firstname.lastname@example.org
Indi Vandyckinhouse_735@randstad.be 03-201 87 71 of email@example.com
03-201 87 71 of firstname.lastname@example.org
2030 ANTWERPEN 3003232313838
Organisatie Randstad Medical
Job Coordinator Flex Lab - CPU Janssen Pharmaceutica
Plaats Merksem (antwerpen)
Naam Randstad Medical
Adres Access Building, Keizer Karellaan 586, bus 8
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