Clinical Research Associate (CRA) – Ophthalmology Device
Type: Contract / Full time
Location: Remote / Field-Based
Travel: Approximately 50–60%
Openings: Two
West Coast: Ideally Arizona, Utah, or Colorado
Midwest: Ideally Minnesota, Illinois, or Michigan
Ideally located within reasonable proximity to a major airport given the travel requirements
Key Responsibilities
- Trial Execution: Handle operational aspects of clinical trials from study start-up through close-out, including supplying materials to clinical sites.
- Site Monitoring: Conduct on-site and remote monitoring visits (qualification, initiation, routine monitoring, and close-out) per the Clinical Monitoring Plan (CMP).
- Compliance & Safety: Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and company Standard Operating Procedures (SOPs); identify and escalate protocol deviations.
- Site Relations & Training: Act as the primary point of contact for study sites, assist with personnel training, and provide device case support.
- Documentation: Maintain accurate study documentation within the Sponsor Trial Master File (TMF) and track study metrics.
Requirements & Qualifications
- Experience: 7+ years of clinical research study monitoring, specifically for medical devices or related fields.
- Specialized Preference: Ophthalmology indication experience is strongly preferred.
- Education: Bachelor of Science (BS) degree or equivalent work experience.
- Regulatory Knowledge: Strong command of federal regulations, ICH GCP, and the Declaration of Helsinki.
- Work Style: Self-starter with independent project management capabilities, strong interpersonal skills, and flexibility for a fast-paced start-up environment.
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