Note: The job is a remote job and is open to candidates in USA. Lumicell is a mission-driven organization focused on improving surgical oncology outcomes through innovative imaging technology. The Clinical Research Associate will support post-market safety studies and registries by leading site start-up and activation, engaging investigators, conducting remote and on-site monitoring, and maintaining compliance, documentation quality, and data integrity.
Responsibilities
- Lead site start-up activities for post-market observational studies, registries, and related real-world evidence initiatives
- Manage site feasibility, qualification, readiness assessment, and activation workflows
- Coordinate collection, review, tracking, and follow-up of essential regulatory and start-up documents
- Support negotiation and execution tracking for Clinical Trial Agreements, Statements of Work, budgets, purchase orders, and related site documentation
- Coordinate site onboarding, including investigator and study staff training, access to study systems, and readiness for first subject enrollment
- Conduct and document Site Initiation Visits (SIVs), including review of protocol requirements, safety reporting expectations, EDC entry, product handling, and study workflow
- Confirm site access to EDC systems, study portals, imaging repositories, training platforms, and other study technologies
- Track site start-up milestones, identify activation risks or delays, and escalate barriers with recommended solutions
- Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, Pharmacovigilance, and external vendors to support timely site activation
- Serve as primary operational contact for assigned clinical sites throughout study conduct
- Conduct remote and on-site monitoring visits, including initiation, routine monitoring, and closeout visits
- Perform risk-based monitoring activities to support protocol compliance, subject safety, data quality, and regulatory compliance
- Review study data for completeness, consistency, and source-document alignment, as applicable to the study design
- Issue, track, and facilitate resolution of site queries in collaboration with Data Management and study teams
- Monitor site performance metrics, enrollment progress, data entry timeliness, protocol adherence, and follow-up completion
- Identify site risks and support corrective and preventive actions when needed
- Build productive relationships with investigators, research coordinators, operating room staff, and other site personnel
- Provide timely guidance, training, and support to sites throughout the study lifecycle
- Conduct retraining when required due to protocol amendments, process changes, monitoring findings, or quality trends
- Serve as an advocate for site success while ensuring adherence to study requirements and documentation standards
- Maintain accurate, complete, and inspection-ready monitoring documentation and site correspondence
- Support Trial Master File (TMF) quality, completeness, and essential document maintenance throughout the study lifecycle
- Document monitoring findings, action items, follow-up, and issue resolution in a timely and traceable manner
- Contribute to audit and inspection readiness activities
- Support development and revision of study tools, training materials, monitoring plans, site-facing handouts, and operational procedures
Skills
- Bachelor's degree in Life Sciences, Nursing, Public Health, Clinical Research, or a related field
- Minimum 3 years of CRA, Clinical Research Coordinator, or Clinical Operations experience
- Experience with site start-up, site activation, and site management activities
- Experience conducting monitoring visits, either remotely or on-site
- Working knowledge of GCP, ISO 14155, applicable FDA regulations, and clinical research documentation standards
- Experience using EDC systems, remote monitoring tools, and clinical trial document repositories
- Strong communication, organization, follow-up, and project management skills
- Ability to travel approximately 25–40%, based on study and site needs
- Medical device clinical research experience
- Experience supporting post-market clinical studies, registries, observational studies, or real-world evidence programs
- Experience working with academic medical centers, surgical oncology programs, or hospital-based research teams
- Experience with eTMF systems, risk-based monitoring approaches, and vendor/site oversight
- Familiarity with post-market safety surveillance, product complaint processes, or pharmacovigilance workflows
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