Clinical Operations Associate

We are seeking a Clinical Operations Associate to lead pre-clinical and clinical research initiatives for our innovative surgical navigation platform.

This position offers a rare chance to be involved in every stage of a medical device's lifecycle, from pre-clinical testing to in-human trials. You will take charge of establishing test environments, sourcing materials, recruiting clinicians, and overseeing device deployment across various sites nationwide. Witness firsthand how your contributions impact clinical practice. In your first year at Illuminant, you'll collaborate with a dedicated team of clinicians and engineers to conduct benchtop verification and cadaveric validation studies, crucial for securing a 510(k) clearance. You'll play a vital role in obtaining regulatory approval for our device and facilitating its commercialization. Additionally, you'll collaborate with executives to craft federal grant proposals and engage with regulatory bodies such as the Institutional Review Board and FDA. Your involvement will extend to co-authoring study manuscripts and presenting findings at national conferences.

Requirements

Responsibilities

• Plan and execute benchtop verification and cadaveric validation studies, overseeing all aspects from material selection to participant coordination.
• Gather, analyze, and present clinical study data through abstracts, manuscripts, and presentations.
• Cultivate and maintain relationships with Key Opinion Leaders nationwide.
• Draft, review, and submit grant proposals to federal agencies and academic societies.
• Prepare and submit documentation to local and central Institutional Review Boards for clinical study initiation.
• Assist in deploying Illuminant's navigation device to pilot sites across the country.

Qualifications

• Reside in West Virginia, preferably Huntington.
• Possess a minimum of 2 years of clinical research experience in academic or industry settings.
• Demonstrate strong oral and written communication skills, particularly in an academic context.
• Have prior experience in a bioskills laboratory.
• Familiarity with clinical settings' organizational structures and etiquette, such as operating rooms.
• Willingness to travel periodically throughout the year to support clinical research functions.
• Bachelor's or Master's degree in a STEM discipline preferred.

Benefits

• Competitive salary and equity compensation package.
• Comprehensive healthcare benefits, including medical, dental, and vision coverage.
• Opportunities for professional development and advancement.
• Flexible work arrangements and remote work options.
• Support for continued education and certification.
• Collaborative and inclusive work environment fostering innovation and growth.
• Salary Range: $80,000 - $100,000 per year, commensurate with experience.