Clinical Lab Scientist I

Job DescriptionJob Description

Flexible for shifts outside of regular working hours (8am-5pm) as well as regular Mon-Fri working days.

SUMMARY:
Responsible for performing high complexity laboratory testing on clinical specimens,
interpreting and reporting results and complying with study protocols, Standard Operating
Procedures, Test Instructions, and related CAP/CLIA Regulations and guidelines. Participates
in scientific studies and activities supporting registrational and non-registrational clinical
trials. Receives general instructions; plans and executes own work.
Responsibilities
• Works under general supervision, to support aspects of clinical testing and sample
processing, adhering to CAP/CLIA regulations and ISO 15189 guidelines.
• Performs high-complexity testing within the CDx CAP/CLIA Laboratory. Monitors performance of
IHC, ISH, molecular assays, and immunoassays; assists with lab failure investigations and
root cause analysis.
• Performs accessioning of biological samples (blood, plasma, tissue) and quality control of
demographic data input. Communicates with clients on held and rejected samples.
• Performs work according to established internal safety guidelines and procedures, and as
specified by appropriate regulatory agencies (SHE, OSHA)
• Critically evaluated quality control and test results against acceptance criteria to support
clinical testing.
• Uses technical writing skills and Good Documentation Practices to complete lab
documentation, SOPs, and Quality documents.
• Participate in routine lab maintenance and lab safety inspections.
• May perform basic troubleshooting for issues related to instrumentation.
• Analyzes alternative approaches to solve problems or develop new perspectives on existing
solutions; initiate and implement process improvements.
• Other duties as assigned by management
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Formal Training/Education
Education Level
Bachelor's Degree Must possess a BS or BA degree in a related discipline
Experience
Years of Experience
1 year experience working in a clinical laboratory
Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience
Knowledge, Skill or Ability Proficiency
• Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and
• laboratory information systems.
• Excellent verbal and written communication skills.
• Strong understanding of good laboratory practices and regulatory compliance.
• Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules.

Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r\n\r\nOur popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.