Scientist I/II
SCIENTIST support CLINICAL TRIAL
Works under general supervision, to support / lead 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 laboratories 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. 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 troubleshoot 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.
May act as a lead for assigned projects or team.
Other Duties: The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as required.Education & Experience
Education:
Minimum (required):
Bachelor's degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
Preferred:
Master's degree
Job-related
Experience:
Minimum (required):
Typically 2 to 6 years of relevant industry experience, including experience in participating clinical research work within a laboratory.
Preferred:
4 to 8 years of relevant industry experience, including experience participating in IVD clinical research work within a laboratory.
Other
Qualifications:
Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs.Estimated Salary: $20 to $28 per hour based on qualifications.
Works under general supervision, to support / lead 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 laboratories 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. 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 troubleshoot 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.
May act as a lead for assigned projects or team.
Other Duties: The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as required.Education & Experience
Education:
Minimum (required):
Bachelor's degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
Preferred:
Master's degree
Job-related
Experience:
Minimum (required):
Typically 2 to 6 years of relevant industry experience, including experience in participating clinical research work within a laboratory.
Preferred:
4 to 8 years of relevant industry experience, including experience participating in IVD clinical research work within a laboratory.
Other
Qualifications:
Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs.Estimated Salary: $20 to $28 per hour based on qualifications.
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