Senior Clinical Research Associate

Luminate

Senior Clinical Research Associate managing pivotal clinical trials to improve cancer care experiences at Luminate. Collaborating with clinical teams and ensuring compliance with regulations and protocols.

Posted 7/28/2026full-timeRemote • Tennessee • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in managing clinical trials and medical device studies, with a strong focus on compliance with GCP, ISO 14155, and FDA regulations. Proficient in Trial Master File management and Electronic Data Capture systems, ensuring high-quality deliverables and effective collaboration with clinical teams.

Highest-signal resume keywords

Trial Master File ManagementElectronic Data Capture SystemsGCP ComplianceISO 14155 KnowledgeFDA Regulations Understanding

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementStudy Document ManagementSite Initiation VisitsClinical Trial ExecutionQuality Assurance

Soft Skills

CollaborationProblem-SolvingCommunicationProactive Support

Industry Keywords

Medical DevicePharmaceutical IndustryClinical TrialsLife SciencesStudy-Specific Processes

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Act as the subject matter expert for Luminate Medical devices, serving as the primary point of contact between sponsor and site staff.
Manage and maintain essential study documents in compliance with sponsor requirements, study-specific processes, and Luminate SOPs.
Collaborate with internal and external clinical teams to support all phases of clinical trials, including study start-up, site initiation visits (SIVs), trial execution, and close-out.
Perform weekly check-ins with clinical sites to track progress, address issues, and provide ongoing support.
Contribute to departmental projects and initiatives, ensuring timely and high-quality deliverables.
Proactively identify and escalate training needs, project updates, quality concerns, and timeline risks to the clinical team.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences or a related field
3 – 5 + years of hands-on experience within the medical device and/or pharmaceutical industry
Prior experience with Trial Master File (TMF) management
Prior experience and proficiency in utilizing Electronic Data Capture (EDC) systems
Deep understanding of GCP, ISO 14155, and FDA regulations for medical devices
Willingness and ability to travel 30-40% during active clinical trials period

Benefits

Comp & perks

Flexible work arrangements