Senior Clinical Research Associate

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $140k - $165k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Magnus Medical

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

🏥 Healthcare

🔧 Hardware

Manufacturing • Healthcare • Hardware

Magnus Medical is a medical technology company that develops and commercializes the SAINT® Neuromodulation System, an FDA-cleared, non-invasive transcranial magnetic stimulation therapy for adults with treatment-resistant major depressive disorder. The system uses structural and functional MRI plus proprietary algorithms to identify personalized brain targets and deliver precise repetitive magnetic stimulation, aiming to produce rapid remission in a five-day treatment course. Magnus Medical supports clinical research, partners with healthcare institutions for commercial deployment, and provides training and provider resources for adoption.

📋 Description

• Independently manage clinical monitoring activities for assigned clinical trial sites, including site selection/qualification, initiation, routine monitoring, and close-out visits • Serve as liaison between Magnus and clinical trial sites, building site relationships and engagement in trials involving sensitive patient populations • Collaborate with peers, leadership, investigators, and key opinion leaders • Review source documents and case report forms to ensure data accuracy and integrity • Monitor protocol compliance, subject safety, informed consent processes, and psychiatric scale administration • Identify and resolve site-level issues and escalate when appropriate • Provide remote and on-site training and support for site staff on protocols, safety reporting, and data collection • Develop study documents, including protocols, CRFs, monitoring plans, and informed consent forms • Collaborate with Regulatory Affairs and Data Management to ensure data quality and timeliness • Mentor and support junior CRAs • Contribute to audit readiness and support regulatory inspections and site audits • Contribute to clinical study operations process improvements

🎯 Requirements

• Bachelor’s or advanced degree in Life Sciences, Nursing, Psychology, or a related field • Minimum 12 years of experience in clinical monitoring • At least 10 years in the medical device industry and/or mental health/CNS therapeutic areas • Strong understanding of ICH-GCP, FDA regulations, and ethical considerations unique to psychiatric research • Ability to independently manage multiple sites and complex protocols • Experience with psychiatric rating scales and vulnerable populations is highly desirable • Strong interpersonal and communication skills with investigators and site staff • Proficiency in EDC systems, CTMS, and Microsoft Office • Willingness to travel up to 75%, depending on study needs • Prior experience working directly for a sponsor organization in mental health is preferred • Familiarity with decentralized or hybrid clinical trial models is preferred • Experience with treatment-resistant mental health trials is preferred • ACRP or SOCRA certification is a plus

🏖️ Benefits

• Annual bonus based on company goals • Equity grant • Inclusive and positive work environment • Equal opportunity employment

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