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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.