Senior Scientist, Regulatory & Clinical Operations
$130,000–$150,000 year
On-siteSouth Plainfield, New Jersey, United States
Job Summary
Serve as the primary clinical coordinator for FDA-regulated studies, owning day-to-day execution from kickoff through completion while working directly with the contracted CRO. Manage site coordination, protocol adherence, and sample logistics including shipment documentation and resolution of discrepancies. Perform hands-on assay execution using automated chemistry and immunoassay platforms, support validation strategies aligned with CLSI guidelines, and troubleshoot technical issues. Coordinate study timelines, data collection, and reporting; develop and review protocols; and execute root cause analysis for deviations. Partner with Quality teams to ensure compliance with FDA, CAP, and CLIA requirements, monitor data integrity, and prepare for laboratory inspections. Author technical reports for regulatory submission and deliver data-driven updates to internal leadership and external stakeholders. This on-site role in Central New Jersey supports the laboratory organization's mission to deliver personalized, accessible healthcare through rigorous scientific execution.
Required Qualifications
- PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field with 4+ years
- Master's degree with 7+ years
- Bachelor's degree with 10+ years of relevant bench experience in a diagnostic or clinical laboratory setting
- Demonstrated experience coordinating clinical or regulated studies, ideally in partnership with a CRO
- Experience supporting FDA-regulated studies (e.g. 510(k), De Novo, or PMA pathways)
- Hands-on experience across assay development and execution lifecycle
- Experience with venous and/or capillary blood-based specimen types and other biological matrices
- Ability to reconcile clinical sample data across tracking and laboratory systems
- Strong project management and organizational skills, with proven ability to manage study timelines and cross-functional coordination
- Ability to perform basic statistical analysis to support interpretation of study data
- Working knowledge of Quality Management Systems (QMS) and design control processes (e.g., FDA QSR, ISO 13485)
- Excellent cross-functional communication skills, with proven ability to present complex study data clearly to both technical and non-technical stakeholders
- Proven ability to work independently and drive study execution from kickoff to completion
- On-site laboratory role based in Central New Jersey
Desired Qualifications
- Experience validating capillary microsampling devices (e.g., Tasso, TAP) for regulated studies
- Experience with at-home or point-of-care diagnostic testing programs
- Experience with dried blood spot (DBS) workflows and stability characterization
- Experience with statistical analysis software (e.g., JMP, Analyse-It)
- Experience with clinical data management and monitoring processes
- Familiarity with patient safety monitoring and adverse event reporting requirements for human subjects research
- Familiarity with emerging biomarker categories relevant to metabolic health, longevity, and consumer wellness testing
- Hands-on familiarity with AI/ML tools (e.g., Python, Copilot Studio) for process improvement or data workflows
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