Clinical Trails Monitor II (Remote)
About the role
Clinical Trials Monitor II
Work Schedule
Clinical Trials Monitor II
Study Feasibility and Protocol Analysis
- Review clinical trial protocols, visit schedules, enrollment assumptions, country requirements, and other study documentation to determine whether and how Labcorp Smart Supply should be used.
- Identify study characteristics that may affect kit supply, such as enrollment patterns, visit schedules, treatment groups, specialty testing, country restrictions, site models, and protocol amendments.
- Determine whether the service should apply to the full study or only selected kits, sites, countries, regions, or visits; document key assumptions, limitations, risks, and mitigations.
Client Consultation and Operational Leadership
- Lead discussions with clients and study teams on supply strategy, start-up quantities, resupply approach, service scope, risks, and performance, translating complex clinical and operational information into clear recommendations.
- Use study data, protocol requirements, and operational experience to challenge requests or assumptions that could increase supply risk, kit waste, or process inefficiency, and recommend practical alternatives.
- Build alignment across stakeholders by clearly communicating decisions, tradeoffs, responsibilities, and required actions.
Start-Up and Resupply Strategy Design
- Develop study-specific start-up kit strategies based on expected enrollment, screening assumptions, site activation plans, visit timing, country lead times, and overall study design.
- Design ongoing resupply strategies that define when kits should be replenished, how much should be supplied, and how to account for factors such as patient demand, expiration, shipping lead time, and study risk.
- Tailor supply strategies by country, site, patient group, visit, or kit type when needed, and keep start-up and resupply approaches aligned as the study changes.
System Configuration, Quality Control, and Activation
- Configure and maintain Labcorp Smart Supply services in internal systems, including study parameters, resupply rules, exclusions, service dates, and quality-control settings.
- Perform detailed quality checks and participate in peer review of supply strategies and system configurations before activation.
- Review initial system-generated orders and pending requests to confirm the service is working as intended, and investigate or correct errors and supply risks.
- Maintain accurate supporting instructions and operational records in applicable systems and repositories.
Active Study Monitoring and Optimization
- Monitor study activity, including enrollment, site activity, kit inventory, orders, expirations, system notifications, and key study milestones, at a frequency appropriate to study risk and complexity.
- Analyze trends to identify supply risks, unexpected ordering behavior, configuration gaps, site-training needs, process deviations, or opportunities to reduce waste.
- Adjust start-up and resupply strategies as study conditions change, including changes in enrollment, site performance, countries, patient groups, visit schedules, kit types, protocol amendments, and end-of-enrollment activities.
- Maintain study risk documentation and ensure significant decisions, assumptions, and remaining risks are documented and communicated.
Exception and Issue Management
- Investigate system exceptions, failed or unmatched orders, site or kit status changes, data issues, and other conditions that may interrupt automated resupply.
- Determine and coordinate the appropriate corrective action, which may include system updates, order intervention, stakeholder escalation, or client communication.
- Make timely, risk-based decisions in ambiguous situations while protecting kit availability, data accuracy, and service integrity.
Performance Analysis and Continuous Improvement
- Use dashboards, trackers, and source data to evaluate kit utilization, waste, ordering activity, enrollment, site behavior, and overall service performance; summarize emerging risks, root causes, and recommended actions.
- Use operational experience and client or site feedback to improve service design, working practices, training, and supporting tools.
Training, Documentation, and Cross-Functional Coordination
- Provide study-specific training and guidance to clients and relevant internal and external study partners.
- Create and maintain accurate study documentation, configuration records, trackers, client materials, risk logs, and amendment records.
- Coordinate responsibilities, timelines, handoffs, and issue resolution across global teams and time zones, and ensure continuity and backup coverage for assigned studies.
Minimum Qualifications
- Bachelor's degree in life sciences, clinical research, healthcare, pharmacy, nursing, business, supply chain, or a related field; equivalent relevant experience may be considered in accordance with company policy.
- Minimum 10 years of relevant experience in clinical trial operations, central laboratory operations, global monitoring, study management, clinical supply, or a related operational role.
Preferred Qualifications
- Experience in clinical trial kit supply, central laboratory services, investigator-site operations, patient recruitment or enrollment workflows, or study-specific supply forecasting.
- Working knowledge of how therapeutic area, patient pathway, study phase, and site operating model can affect recruitment, visit execution, and kit demand.
- Experience working with rule-based operational services, workflow tools, or clinical systems.
- Experience facilitating client meetings, delivering training, completing quality reviews, and managing operational risk or change in a regulated environment.
Additional Job Standards
- Advanced critical thinking and the ability to connect study design, patient flow, site activity, enrollment, logistics, system logic, and operational impact.
- Constructive challenge and influencing skills, including the ability to push back professionally, explain evidence and trade-offs, and propose workable alternatives.
- Clear, concise, and confident written and verbal communication, with strong facilitation and client-facing skills and the ability to simplify complex information for different audiences.
- Sound judgment, attention to detail, and disciplined quality-control practices.
- Data literacy and proficiency in interpreting dashboards, spreadsheets, trends, exceptions, and operational metrics.
- Strong understanding of clinical trial operations, including study start-up, site activation, screening, enrollment, patient visits, amendments, closeout, site challenges, shipping constraints, and clinical supply risk.
- Ability to learn complex systems and apply configurable business rules accurately.
- Strong collaboration, accountability, adaptability, and prioritization across multiple global studies and time zones.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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