Clinical Lab Safety Analyst 2 at Pharmaceutical Research Associates, Inc. in Lenexa, Kansas

Job Description:

Pharmaceutical Research Associates, Inc.

Clinical Lab Safety Analyst 2

US-KS-Lenexa


Job ID: 2021-86101
Type: US-Midwest
# of Openings: 1
Category: Early Development Services

PRA Health Sciences

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

Lead Clinical Safety Laboratory Associate 2

We are currently hiring for two brand new, lead positions that will be core roles for our new, state of the art clinical safety laboratory located in Lenexa, KS. These individuals will be part of planning for and bringing on new equipment, and will be involved in the generation of lab processes. For these two strategic hires, we are seeking candidates that have experience working in CLIA certified labs.

Overview:

The Lab Associate is part of the operational team within the sample preparation laboratory. The Lab Associate ensures the appropriate collection, processing, storage and shipment of samples. Daily tasks may involve maintenance of equipment, processing and shipment of samples. The Lab Associate is part of the study team that is responsible for the execution of the study.

General activities:

• Routine sample processing with different techniques

• Interpreting and data processing/reporting results and approve or reject sample analysis

• Identifying deviations and performing investigation

• Performs (peer) data review for quality control

• Has a thorough understanding and complies with GxP and other appropriate regulations

• Identifies and reports irregularities identified with any aspects of work

• Economically utilizes materials in operation of daily tasks

• Ensures on-time task completion to support the overall goal of on-time study completion

• Assists in the organization and housekeeping of the laboratory

• In study planning (daily basis)

• Understands the scientific principles behind analysis methods utilized

• Comprehensive sample processing with different techniques

• Instrument management and troubleshooting (documentation, maintenance and calibration)

• Takes initiative in process development and writes SOP’s and work instructions

• Trains/Mentors Lab Analysts

• Solving problems in the analysis process

• Preserving overview of method validation/development and analysis of a single project

• Keeps current and seeks to grow knowledge in analysis field through scientific journals, training, on-line study, etc.

Qualifications

Qualifications:

• Medical, Laboratory or Life Science education
• They will be part of planning for and bringing on new equipment, and will be involved in the generation of lab processes.
• Must be comfortable with lab work and paperwork (assay qualification and SOP creation).
• Able to learn, document, and then train future staff.
• Experience in the relevant testing areas: Chemistry, Immunoassay, Coagulation/hemostasis, Hematology, Urinalysis.
• LIMS/LIS (Laboratory Information Management System) experience.
• Familiar with CLIA/COLA/CAP regulations and proficiency testing.
• Candidates with experience working in CLIA certified labs

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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