Clinical Biomarker Lab Operations Associate at Net2Source (N2S) in New Haven, CT

Job description

• Join a Global Leader in Workforce Solutions – Net2Source Inc.
• Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.
• Title-Clinical Biomarker Lab Operations Associate
• Location-New Haven,CT,USA,06511
• Duration- 12 months contract
• This is a development opportunity for a lab generalist looking to specialize in bioanalytical quality and operations. The position is primarily office-based (approximately 75%) with a focus on quality oversight, while also requiring hands-on lab support (approximately 25%) during peak times. A Clinical Biomarker Lab Operations Associate will support early-phase clinical trials by monitoring laboratory inventory, data, and documents to ensure GxP compliance. The role will contribute to continuous improvement efforts and is expected to provide bench support when lab workload is high.

Responsibilities

• • Enhance Operational Excellence: Leverage problem-solving skills to increase the efficiency of lab inventory and asset management, to monitor and report all quality incidents in order to assist in the identification of procedural gaps, to continuously adapt to new GxP regulations, and to remain inspection-ready
• • Master the GxP Document Lifecycle: Manage laboratory assets (qualification and maintenance reports), laboratory test methods (procedural documents and training tasks), method validation study plans and reports, clinical biomarker study plans and reports to include quality review, table creation, and submission-ready formatting
• • Ensure Data Integrity: Quality review of laboratory data to maintain accuracy against source, leverage/learn new software or artificial intelligence tools to increase efficiency in data table creation, and assist in the qualification of automated procedures for data table creation
• • Drive Project Timelines: Communicate and coordinate with Biomarker Lab Head, Biomarker Scientists (Project Leads and Analysts) to successfully execute clinical biomarker project milestones; Attend biweekly Biomarker Study Management Meetings to discuss project status and anticipated workflow challenges and to discuss quality metrics and follow-up investigations
• • Collaborate Across a Global Organization: Engage external departments in a project-dependent manner (e.g. Global Workplace Experience/Laboratory Instrument Services, Global PCRU Quality Assurance & Training, Global Digital/Creation Center, Clinical and Translational Biomarkers) to ensure all deliverables are completed within team expectations for quality and time
• • Provide Critical Lab Support: As needed, assist with hands-on lab activities, including instrument maintenance and human biospecimen processing/management, to support the team during periods of high workload and ensure project timelines are met.

Requirements

• • Bachelor's degree in a biological or biochemical science
• • 2-4 years of hands-on laboratory experience, with a demonstrated ability to apply that scientific understanding to process workflows for managing data, documents, and/or laboratory inventory
• • Advanced proficiency using standard applications: Microsoft Teams, Microsoft Excel, Microsoft Word, Adobe Acrobat
• • Strong computer skills to quickly learn, retain, and apply knowledge to new file and data management tools, e.g. IDBS E-WorkBook, Veeva Vault, Generis CARA
• • Exceptional attention to detail to identify non-compliance or discrepancies
• • Exceptional time management to meet deadlines
• • Strong written and verbal communication skills within and across departments
• • Organized to multi-task and comply with both general operating procedures and project-specific requirements
• • Independent problem-solving skills
• • Courage to suggest process improvements that enhance efficiency and/or product quality
• • Positive attitude with a desire to learn and contribute to large team projects that occasionally require flexible working hours
• • Preferred qualifications: Firm understanding of immunoassay techniques and readouts (e.g. ELISA/ECL assays, or flow cytometry assays), Firm understanding of descriptive statistics and regression analyses, work experience in a regulated lab (GxP, CLIA) or quality assurance department

Skills

Required

• Independent problem-solving skills