Scientist - Clinical Trial Support Lab in Pleasanton, CA at Apex Life Sciences

Date Posted: 9/11/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Scientist responsible for performing high complexity laboratory testing on clinical specimens, interpreting and reporting results and complying with study protocols, IRBs , Manuals of Operations, Test Instructions, and related Code of Federal Regulations and ICH guidelines. Participates in scientific studies and activities supporting registrational and non-registrational clinical trials.

Responsibilities

  • 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 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
  • Keeps supervisor or project leader informed of project status, 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 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 own 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 perform basic troubleshooting for issues related to instrumentation.
  • Receives general instructions; plans and executes own work
  • Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions
  • May establish and work with individuals or teams outside of immediate functional area


Qualifications:

  • Bachelors degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
  • 1 year preferred of relevant industry experience, including experience in participating clinical research work within a laboratory
  • 2+ years of basic laboratory experience in either academic or industry setting required
  • Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs
  • Excellent attention to detail, ability to multi-task and be flexible with tasks and schedules a must
  • May travel domestically up to 10%

***For immediate consideration, please email your updated resume to bfreeman@apexlifesciences.com with 'Scientist - Clinical Trial Support Lab' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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