Senior Clinical Research Associate

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Serve as the subject matter expert for Luminate Medical devices, acting as the main liaison between sponsors and site personnel.

• Oversee and manage critical study documentation in accordance with sponsor specifications, study-related processes, and Luminate SOPs.

• Collaborate with both internal and external clinical teams to assist in all stages of clinical trials, including study initiation, site initiation visits (SIVs), trial execution, and closing procedures.

• Conduct weekly check-ins with clinical sites to monitor progress, resolve issues, and offer continuous support.

• Contribute to departmental projects and initiatives, ensuring the timely delivery of high-quality outputs.

• Proactively identify and communicate training requirements, project updates, quality issues, and timeline risks to the clinical team.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related discipline.

• 3 – 5 + years of practical experience in the medical device and/or pharmaceutical sector.

• Previous experience in managing Trial Master Files (TMF).

• Familiarity and proficiency in using Electronic Data Capture (EDC) systems.

• Comprehensive understanding of GCP, ISO 14155, and FDA regulations pertaining to medical devices.

• Willingness and capacity to travel 30-40% during active clinical trial periods.

🏝️ Benefits

• Flexible work arrangements.