Clinical Research Associate – Contract

🔥 5 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Lumicell

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

💰 $28.7M Series C on 2017-10

Manufacturing • Healthcare • Biotechnology

Lumicell is a privately held company focused on innovative fluorescence-guided technologies for cancer surgery with the potential to improve patient outcomes and reduce healthcare costs. The company’s first product is the Lumicell Direct Visualization System, designed to provide real-time illumination of cancerous tissue within the breast cavity during the initial lumpectomy, potentially reducing repeat surgeries. Lumicell’s proprietary, pan-oncologic optical imaging agent is also being explored across a wide variety of solid tumor indications. The company aims to enhance the standard of care treatment by guiding the resection of additional cancer that may have otherwise been left behind.

📋 Description

• 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. • 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. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Competitive salary • Remote work options • Professional development opportunities • Health insurance • Paid time off