Sr. Clinical Biospecimen Operations Associate
Skills
- Project management and timeline management
- Biospecimen handling and biobanking best practices
- Familiarity with TMF/eTMF organization
- Competency in SOPs, ICH-GCP and FDA regulations
- Proficiency in MS Word, Excel and PowerPoint
- Ability to develop dashboards and interpret KPIs
- Strong verbal and written communication
- Analytical problem solving and attention to detail
- Ability to work independently in a fast-paced environment
- Experience handling PHI and completing HIPAA/GCP training
Responsibilities
- Oversee study operational activities from start-up through close-out, supporting timelines, kick-off, and planning
- Monitor study health using KPIs (e.g., TAT, TNP), manage milestones, and escalate risks with mitigation plans
- Develop and maintain dashboards and KPIs with Data and Sample Management; present metrics to stakeholders
- Escalate and resolve data management and sample management issues impacting testing or reporting
- Review protocol sample collection requirements for alignment with SOW, study plans and policies
- Facilitate internal and external meetings; prepare agendas and minutes
- Assist with study plans, SOPs, work instructions, and eTMF setup/maintenance
- Monitor for protocol deviations or data discrepancies and issue clarification forms as needed
- Handle PHI in paper and electronic form in compliance with HIPAA/GCP and related trainings
Education
- BA/BS degree in life sciences or related field (or equivalent)
- Training or certification in HIPAA/PHI privacy, human subjects protection and GCP
- Willingness to complete required company trainings and pass background check
Benefits
- Comprehensive medical, dental, and vision coverage
- Life and disability insurance
- 401(k) plan
- Fertility care benefits and free testing for employees and immediate families
- Pregnancy and baby bonding leave
- Commuter benefits
- Generous employee referral program
Average salary estimate
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CONCEIVE innovative breakthroughs in science and technologyDELIVER actionable information to improve reproductive health, cancer, and organ transplant careHelp patients THRIVE by getting earlier, more accurate health information, and better qualit...
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