Planet Pharma
Job Description: 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. Essential Responsibilities
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. Support Clinical Operations in sample shipping, receiving, and investigational or follow-up internal testing. Perform Clinical Validation testing and accurately complete and file all applicable documentation in compliance with Protocols, IRBs, Manual of Operations, Test Instructions, related global regulations, and GCP guidelines. Use technical writing skills and Good Documentation Practices, assuming accountability for own project documentation. Critically evaluate quality control and test results against acceptance criteria to support project decisions. Analyze and interpret experimental data using various data analysis software and/or applying quantitative methods. Participate in external regulatory/FDA or internal audits and inspections when called upon. Communicate results of experiments and present findings at internal meetings. Establish and work with individuals or teams outside of the immediate functional area and across business units. Keep supervisor/project leader informed of project status, particularly of significant findings and results in critical problem areas. Perform work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA). Participate in routine lab maintenance, lab safety, ISO, and QSR implementation. Maintain laboratory and all trial documents in an inspection-ready state. Participate in investigational or exploratory testing to support affiliates and CIR on resolving customer questions/complaints or new initiatives. Perform basic troubleshooting for issues related to instrumentation. Analyze alternative approaches to solve problems or develop new perspectives on existing solutions. Minimum Qualifications
Bachelor’s degree in Biological/Life Sciences, Chemistry, Biochemistry, or a related field. 0 years of work experience required, 1-2 years preferred, of relevant industry experience, including experience participating in clinical research work within a laboratory. Required minimum 1 year of basic laboratory experience in either an 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, including pipette handling, understanding protocols, and safely handling biological and potentially hazardous materials. 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. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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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. Support Clinical Operations in sample shipping, receiving, and investigational or follow-up internal testing. Perform Clinical Validation testing and accurately complete and file all applicable documentation in compliance with Protocols, IRBs, Manual of Operations, Test Instructions, related global regulations, and GCP guidelines. Use technical writing skills and Good Documentation Practices, assuming accountability for own project documentation. Critically evaluate quality control and test results against acceptance criteria to support project decisions. Analyze and interpret experimental data using various data analysis software and/or applying quantitative methods. Participate in external regulatory/FDA or internal audits and inspections when called upon. Communicate results of experiments and present findings at internal meetings. Establish and work with individuals or teams outside of the immediate functional area and across business units. Keep supervisor/project leader informed of project status, particularly of significant findings and results in critical problem areas. Perform work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA). Participate in routine lab maintenance, lab safety, ISO, and QSR implementation. Maintain laboratory and all trial documents in an inspection-ready state. Participate in investigational or exploratory testing to support affiliates and CIR on resolving customer questions/complaints or new initiatives. Perform basic troubleshooting for issues related to instrumentation. Analyze alternative approaches to solve problems or develop new perspectives on existing solutions. Minimum Qualifications
Bachelor’s degree in Biological/Life Sciences, Chemistry, Biochemistry, or a related field. 0 years of work experience required, 1-2 years preferred, of relevant industry experience, including experience participating in clinical research work within a laboratory. Required minimum 1 year of basic laboratory experience in either an 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, including pipette handling, understanding protocols, and safely handling biological and potentially hazardous materials. 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. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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