Advanced Clinical
Join to apply for the
Scientist I
role at
Advanced Clinical Overview We are currently searching for a skilled professional to join a well-known client’s team as a Scientist in Oro Valley, Arizona. The Scientist will be 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. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. 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 Experience Minimum of 1 year of basic laboratory experience required Education Minimum of Bachelor’s Degree in Biological/Life Sciences, Chemistry, Biochemistry or related field required To Be a Best-fit Your Strengths Must Include
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. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates.
#J-18808-Ljbffr
Scientist I
role at
Advanced Clinical Overview We are currently searching for a skilled professional to join a well-known client’s team as a Scientist in Oro Valley, Arizona. The Scientist will be 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. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. 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 Experience Minimum of 1 year of basic laboratory experience required Education Minimum of Bachelor’s Degree in Biological/Life Sciences, Chemistry, Biochemistry or related field required To Be a Best-fit Your Strengths Must Include
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. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates.
#J-18808-Ljbffr