Scientist I, Clinical Trial Support Lab

Target Pay Rate: 30-35/hr **salary will be commensurate with experience

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. Organizes, conducts and monitors experiments utilizing established and published procedures and technical and theoretical understanding. Requires excellent attention to detail, ability to multi-task and be flexible with tasks and schedules. Receives general instructions; plans and executes own work.

ESSENTIAL RESPONSIBILITIES:
? Under general supervision, 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 Clinical Operations as a sponsor in sample shipping, receiving and investigational or follow up internal testing.
? 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, Manual of Operations, Test Instructions, related global regulations and GCP guidelines.
? Uses technical writing skills/Good Documentation Practices and assumes accountability for own project documentation in either the study trial binder, trial master file or electronic laboratory notebook, ensuring applicable methods and results are recorded timely, accurately and consistently, and according to established formats.
? Critically evaluates quality control and test results against acceptance criteria to support project decisions.
? Analyzes and interprets experimental data using various data analysis software and/or applying quantitative methods.

? May participate in external regulatory/FDA or internal audits and inspections when called upon as either a sponsor or a trial site.
? Communicates results of experiments and may present findings at internal meetings.
? May establish and work with individuals or teams outside of immediate functional area and across business units.
? 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)
? Participates in routine lab maintenance, lab safety, ISO, and QSR implementation.
? Maintains laboratory and all trial documents in an inspection ready state.
? May participate in investigational or exploratory testing to support affiliates and CIR on resolving customer questions/complaints or new initiatives.
? May perform basic troubleshooting for issues related to instrumentation.
? Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions.
? Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.
? May provide input for developing training materials to support internal lab training program.

MINIMUM QUALIFICATIONS:

Formal Training/Education:
? Bachelor’s degree in Biological/Life Sciences, Chemistry, Biochemistry or related field.

Experience:
? 0 years work experience required, 1-2 year preferred of relevant industry experience, including experience
in participating clinical research work within a laboratory.
? Required minimum 1 year 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
? Demonstrated laboratory skills (pipette handling, understanding protocols, familiarity with safely
handling biological and potentially hazardous materials and familiarity with automation)
? Familiarity with spreadsheet and office programs (Microsoft Office and Google Suite)
? Strong interpersonal communication skills.
? Ability to work independently and as part of a team.

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