Senior CRA

Senior Clinical Research Associate

Remote (U.S.)

$115,000 - $135,000

Job Description

EPM Scientific is partnered with an innovative medical device company developing next-generation implantable hearing technologies designed to improve outcomes for individuals with hearing loss. The organization is seeking a Senior Clinical Research Associate to support the execution of U.S. clinical studies and serve as a key member of the Clinical Operations team.

This individual will work closely with investigators, audiologists, clinical research coordinators, CROs, and internal stakeholders to ensure successful study execution from site initiation through study closeout. This is an excellent opportunity for a clinical research professional who enjoys field-based engagement, investigator collaboration, and making a direct impact on the development of novel hearing restoration technologies.

Key Qualifications

• Bachelor's degree in Audiology, Hearing Sciences, Life Sciences, Nursing, or a related field.
• Au.D. strongly preferred with cochlear implant or implantable hearing device experience.
• Candidates without an audiology background must possess an MD and direct cochlear implant experience.
• 3+ years of clinical research experience within medical devices.
• Experience conducting monitoring visits and managing investigative sites.
• Strong knowledge of GCP, FDA regulations, and clinical trial best practices.
• Experience supporting Class III medical device studies preferred.
• Cochlear implant, hearing implant, neurotology, otology, or audiology-related experience highly preferred.
• Strong communication, training, and relationship management skills.
• Willingness to travel extensively throughout the United States.

Roles & Responsibilities

• Conduct site qualification, initiation, interim monitoring, and closeout visits.
• Serve as the primary liaison between investigative sites and the sponsor study team.
• Build and maintain strong relationships with investigators, research coordinators, and site personnel.
• Monitor patient safety, protocol compliance, data quality, and study progress.
• Review regulatory and study documentation to ensure compliance with GCP and study requirements.
• Identify, document, and follow up on protocol deviations, site issues, and corrective actions.
• Support site training initiatives related to protocol requirements, device usage, and clinical procedures.
• Collaborate closely with Clinical Affairs, Regulatory Affairs, Quality, Data Management, and Engineering teams.
• Prepare monitoring reports and maintain accurate trial documentation.
• Support enrollment, retention, and follow-up activities across clinical study sites.
• Assist with investigator meetings, study training programs, and clinical education initiatives.
• Ensure studies are conducted in accordance with FDA regulations, GCP, and internal quality standards.

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) with company contribution
• Competitive PTO and paid holidays