Scientist I /II

Location: Pleasanton, CA, United States
Date Posted: 04-20-2018
Job Title: Scientist I /II
Location: Pleasanton, CA​​​​.



JOB SUMMARY:
Responsible for conducting basic laboratory activities along with complete and accurate documentation of all activities in the support of registrational and non-registrational clinical trials.
 
DISTINGUISHING CHARACTERISTICS:
This job is the first (entry level) in a series of four (4)jobs.  The Scientist I must demonstrate solid laboratory techniques, thorough documentation, and high aptitude for learning the clinical validation aspects of IVD development.
 
ESSENTIAL RESPONSIBILITIES:
  • After introduction to work processes, begins to organize and conduct laboratory activities for Clinical Trials, Proficiency Testing, Sample Characterization, Panel Builds, and general exploratory testing.
  • Works under general supervision, to support aspects of Panel build and sample processing projects adhering to required standards to produce Test Panels and Sample Sets for use in Clinical Validation Studies. 
  • Supports the laboratory's participation as a Clinical Testing Site through performing Clinical Validation testing and the accurate completion and filing of all applicable documentation in compliance with Protocols, IRBs, Manuals of Operations, Test Instructions, and related Code of Federal Regulations and ICH guidelines. 
  • Provides sample tracking and testing support to the Proficiency Testing Program (CAP / VQA).
  • Keeps supervisor, Director / Principal Investigator, and study team informed of testing status as instructed, particularly of significant findings and results in critical problem areas. 
  • Performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA)
  • Critically evaluates quality control, test results against acceptance criteria to support project decisions.  Uses technical writing skills and Good Documentation Practices to complete project documentation and produce reports and documents.  May present findings at internal meeting.
  • Assumes accountability for project documentation, ensuring applicable methods and results are recorded timely, accurately and consistently, and according to established formats.
  • Participates in routine lab maintenance, lab safety, ISO, and QSR implementation.
    May troubleshoot issues related to instrumentation.
  • Receives general instructions; plans and executes own work.  
  • Supports the maintenance of laboratory inventory.
MINIMUM QUALIFICATIONS:
 
Formal Training/Education:
  • Bachelor's degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience. 
Experience:
  • Demonstrated experience in basic laboratory techniques and good laboratory practices
  • Minimum 0-3 years of clinical laboratory experience
  • Preferred: 1-2 years of clinical laboratory experience with clinical trial experience
Knowledge, Skills, and Abilities:
  • Experience documenting detailed laboratory activities
  • Knowledge of Good Clinical Practices
  • Knowledge of Good Documentation Practices
  • Preferred experience in documenting Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs
 
TRAVEL REQUIREMENTS:
Approximately <5% of domestic travel required.


Scientist II
JOB SUMMARY:
Responsible for coordinating and conducting a variety ofclinical trial laboratory activities along with the complete and accurate documentation of all activities in the support of registrational and non-registrational clinical trials.
 
DISTINGUISHING CHARACTERISTICS:
This job is the second (2nd) in a series of four (4)jobs.  The Scientist IIhas mastered the basic laboratory techniques and documentation requirements across the services of the Clinical Trial Support Lab and begins to coordinate activities, interact with the study teams and may become an expert in various instruments and assays to begin training internal and external laboratory personnel.
 
ESSENTIAL RESPONSIBILITIES:
  • Works directly with study teams to collect and document various aspects of project specifications and effectively communicates these specifications to the laboratory staff.
  • Works under general supervision, to support / coordinate all aspects of Panel build and sample processing projects adhering to required standards to produce Test Panels and Sample Sets for use in Clinical Validation Studies. 
  • Supports the laboratory's participation as a Clinical Testing Site through coordinating / performing Clinical Validation testing and the accurate completion and filing of all applicable documentation in compliance with Protocols, IRBs, Manuals of Operations, Test Instructions, and related Code of Federal Regulations and ICH guidelines.
  • Coordinates and provides sample tracking and testing support to the Proficiency Testing Program (CAP / VQA).
  • Keeps supervisor, Director / Principal Investigator, and study team informed of testing status as instructed, particularly of significant findings and results in critical problem areas. 
  • Performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA)
  • Critically evaluates all aspects of laboratory activities, quality control,and test results against acceptance criteria to support project decisions. 
  • Uses technical writing skills and Good Documentation Practices to complete project documentation and produce reports and documents.  May present findings at internal meeting.
  • Assumes accountability for project documentation, ensuring applicable methods and results are recorded timely, accurately and consistently, and according to established formats.
  • Participates in routine lab maintenance, lab safety, ISO, and QSR implementation.
    May troubleshoot issues related to instrumentation.
  • Receives general instructions; plans and executes own work and may begin to lead lab projects.  
  • Supports / coordinates the maintenance of laboratory inventory.
  • May be responsible as a qualified trainer of specific instruments / assays and conduct the training of internal and external laboratory personnel (traveling trainer).
MINIMUM QUALIFICATIONS:
 
Formal Training/Education:
  • Bachelor's degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience. 
Experience:
  • Minimum 2 to 4  years of relevant industry experience, including experience participating in clinical research work within a laboratory
  • Preferred: 3 years of relevant industry experience, including experience participating in IVD clinical research work within a laboratory.
Knowledge, Skills, and Abilities:
  • Working knowledge of Clinical Trial testing for IVD development
  • Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs
  • Knowledge of Good Clinical Practices
  • Knowledge of Good Documentation Practices
TRAVEL REQUIREMENTS:
Approximately 5-10% of domestic travel required (could be up to 25% as a traveling trainer)




Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com
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