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Clinical Affairs Associate - Biorepository in Sunnyvale, California at Cepheid

Date Posted: 2/8/2019

Job Snapshot

Job Description

Job ID: CEP002853

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

JOB SUMMARY:
Responsible for the daily operation of the specimen biorepository following standard operating procedures. This includes but not limited to obtaining and coordinating the receipt, storage, and withdrawal of specimens, samples, and materials using a computerized repository system. Assembles and displays data for the storage and retrieval of specimens and for report preparation; processes and aliquots specimens; uses personal protective equipment and strictly adheres to safety protocols. This position also requires working knowledge of Microsoft Excel and Word programs and adaption to the use of other computer programs as required.
The ideal candidate has laboratory experience with clinical samples and biorepositories.  In addition the candidate has the ability to work independently, is goal-oriented and organized and be able to thrive in an atmosphere of shifting demands and priorities. The candidate should possess excellent oral and written communication skills as well as strong computer skills.



KEY RESPONSIBILITIES:

  • Aid in the development of and ensure compliance with the standard operating procedures of the biorepository
  • Receives handles and inventories specimens at temperatures ranging from ambient to -80°C, and having potentially hazardous properties. Requires the use of personal protective equipment and adherence to strict safety protocols.
  • Prepares samples for pickup, courier delivery and shipment. Enters data into on-line repository database for sample tracking and management.
  • Maintains repository files for validation of data and preparation of reports; reviews accumulated data for accuracy and prepares reports of information and sample data
  • Performs routine and non-routine queries and generates standard and ad hoc reports using the database
  • Routinely inventories the storage units
  • Monitors temperatures of storage refrigerators/freezers
  • Review protocols for specimen collection and handling requirements
  • Assist with specimen acquisition from Clinical sites and Vendors
  • Serve as liaison to biobanking studies and establish relationships with  key stakeholders and appropriate project team members
  • Assist in establishing best practices and standards for sample collection management
  • Assists in training of others following standard operating procedures in the effective use of equipment, methods of storage and retrieval, serum separation, aliquoting, general laboratory procedures and systematic data entry
  • Is fully engaged, agile and able to take on additional duties/responsibilities according to business needs.

Job Requirements



Qualifications

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
  • Ability to communicate effectively with all levels of technical and professional personnel
  • Ability to use  Windows,  Excel and Word
  • Knowledge of methods to handle, process, and store specimens using a computerized storage and retrieval system
  • Knowledge of GCP, GDP, IRB, IATA
  • Experience in clinical or research laboratory
  • Knowledge of Biosafety level 2
  • Knowledge of Universal Precautions, general laboratory and quality control/assurance procedures

PREFERRED QUALIFICATIONS:
  • BS in life science or equivalent, 0-2 yrs experience
  • Excellent customer service and time management skills

WORKING CONDITIONS: 


Environment: Office and Biorepository (BSL2)

PHYSICAL DEMANDS:

  • Must be able to lift and carry a minimum of 35 lbs.
  • Must be able to process and handle materials frozen on dry ice (-78°C) for up to 6 hours per day
  • Must be able to work in walk-in freezers/refrigerators up to 5 hour per day
  • Must be able to use a computer up to 6 hours per day 
  • Participation in Hepatitis B vaccination program recommended


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.