Software Guidance & Assistance, Inc., (SGA), is searching for a CDx Clinical Lab Scientist I - RTD for a contract assignment with one of our premier Pharmaceutical clients in Tucson, AZ .
Responsibilities :
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.
- 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.
- Lead clinical and medical research studies
- Analyze clinical trial data and publish findings
- Ensure compliance with medical research regulations
- Collaborate with healthcare professionals and research teams
- Support drug and therapy development efforts
- Other duties as assigned by management.
Required Skills :
- Bachelor's Degree. Must possess a BS or BA degree in a related discipline
- Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience.
- Are equivalencies acceptable? No
- 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.
- Bachelor's degree in Life Sciences (BA/BS)
- 1-3 years of experience in a clinical lab setting; histology or IHC experience preferred
- Demonstrates strong teamwork and adaptability, combining a willingness to follow direction with the self-motivation needed to deliver consistent results.
- 1-3 years of experience
- Strong problem-solving skills
- Excellent communication abilities
- Knowledge of industry best practices
Preferred Skills :
- 1 year experience working in a clinical laboratory
- Histotechnologist certification (HT or HTL)
- Experience in clinical trials preferred
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
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