Lab Scientist I

Job description

·  Job facts

JOB SUMMARY:
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. Requires excellent attention to detail, ability to multi-task and be flexible with tasks and schedules.

ESSENTIAL 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'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.
·  Keeps supervisor/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 or RMD.
·  Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.

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:

·  0 years required, 1 year preferred of relevant industry experience, including experience in participating clinical research work within a laboratory
·  Required minimum 2 years of basic laboratory experience in either academic or industry setting.

Knowledge, Skills, and Abilities:

·  Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs

TRAVEL REQUIREMENTS:
Approximately 10% of domestic travel may be required.

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.