Clinical Research Laboratory

il y a 4 jours

Anderlecht, Belgique Pfizer Temps plein

Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Clinical Research Laboratory /Senior Analytical Technician

Your responsibilities:

- The Clinical Research Laboratory Senior analytical Technician’s main responsibility includes proper sample management, storage and all analytical work on a day-to-day level.
- Involved in different various activities in the laboratory.
- Training of new colleagues and updating the training materials
- Inventory management and controls for the laboratory
- Optimize Operational Control and Effectiveness
- Fosters positive community attitudes and volunteer trust through professional behavior and ongoing communication.

The Clinical Research Laboratory Senior Technician is responsible for the day-to-day Laboratory work.
- Ensure the control of the laboratory environment, safety specification, the maintenance and calibration of laboratory material required to conduct clinical trials.
- Responsible for orders of the laboratory (identification of supplier, making contact, order tracking,)
- Must be able to follow written and oral instructions and comply with safety and laboratory procedures.
- Creation/review and update SOP’s of the laboratory when it is necessary

Sample Management
- Responsible to ensurequality throughout sample processes and beyond
- Manage all necessary preparations in regard to the laboratory for adequate execution of a protocol in a timely manner
- Ensure proper lab samples handling (documents for staff use: trolley sheet, centrifugation sheet, urine collection sheet, order Lab supplies, etc )
- Support setting up of EDCMS as appropriate
- Ensure proper inventory management in Eworkbook

Analytical
- Perform all routine and special clinical chemistry, hematological, coagulation, and urinalysis, immunological and other tests according to the Standard Operating Procedures.
- Implement and validate new assays. May assist with assay development. Coordinates with the guidance of the Managers new methods validation and instruments implementation.
- Perform all quality control checks (monitor trends) on instruments, reagents, and techniques, maintain quality control and calibration data.
- Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required during experimental procedures.
- Perform and document required routine maintenance and calibration of laboratory instruments.
- Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
- Process samples for analysis or storage. Utilize PIMS/LIMS computer system for the processing of samples.
- Assist the Laboratory Quality Coordinator with preparation for Internal audits and BELAC audits.
- Identify new lab equipment if necessary
- Support new lab technique (biomarkers, material, etc )
- Assisting in the validation of methods when it is necessary

Other
- Maintain accuracy, accessibility, and confidentiality in volunteer/patient records
- Record and communicate or resolve any discrepancy to study protocols in regards to laboratory
- Facilitate positive attitude and trust by the volunteer/patient population toward participation in clinical research
- Ensure development of new procedures required by the protocol as “superuser” and train staff accordingly
- Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report
- May Participate in protocol reviews and provid specialized oversight and technical assistance in regards to the laboratory and liaise with the PI and the Clinical Project Manager
- May be assigned to be mentor/sponsor for a new colleague

Training
- Participate in training courses as appropriate
- Organize and assist in the training of PCRU staff and contractors with less experience and expertise
- May Ensure Lab training requirements are fully achieved for protocol execution and for all protocol related procedures
- Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation

Your Skills:

- Minimum of a Diploma/Bachelor degree Medical Biology or equivalenty
- Superior written and verbal skills are essential;including the ability to communicate complicated research priniciples in easily understandable language.
- Must b

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