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Lumicell is seeking an experienced and highly motivated Clinical Research Associate (CRA) to support the execution of a post-market safety study and a post-market registry evaluating the safety, performance, and clinical utility of Lumicell technologies. This position will play a critical role in site start-up, site activation, investigator engagement, risk-based monitoring, and ongoing site oversight across academic and community surgical centers.

The CRA will serve as a primary operational liaison between Lumicell and participating clinical sites, ensuring studies are conducted in accordance with the protocol, Good Clinical Practice (GCP), ISO 14155, applicable FDA requirements, and company procedures. The ideal candidate is proactive, highly organized, site-service oriented, and comfortable helping sites move efficiently from feasibility through activation, enrollment, follow-up, and closeout.

Position Focus: This role is focused on site start-up, activation readiness, investigator engagement, and conducting remote and on-site monitoring visits for Lumicell post-market research programs

Primary Value to the Organization: The CRA will help accelerate site activation, maintain inspection-ready documentation, support data quality, and keep post-market safety and registry activities moving across participating sites in accordance with study management and monitoring plans

Key Responsibilities

1. Site Start-Up and Site Activation

· 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.

2. Site Management and Monitoring

· 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.

3. Investigator and Site Relationship Management

· 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.

4. Study Documentation, Compliance, and Inspection Readiness

· 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.

Qualifications

Required

· 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.

Preferred

· 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.

Success Factors

· Effectively drives site activation timelines and keeps stakeholders aligned on next steps.

· Builds trust with investigators and coordinators while maintaining clear compliance expectations.

· Balances urgency, documentation quality, and practical site support.

· Demonstrates strong attention to detail and audit-ready follow-through.

· Manages multiple sites, priorities, and stakeholders in a fast-paced environment.

· Maintains a strong commitment to subject safety, data integrity, and regulatory compliance.

Why Join Lumicell?

Join a mission-driven organization focused on improving surgical oncology outcomes through innovative imaging technology. This role offers the opportunity to contribute directly to post-market research programs, collaborate with leading cancer centers and community sites, and help generate real-world evidence that supports patient care and product safety surveillance.

Lumicell is committed to a diverse and inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.