Company background
Magnus Medical, Inc. (“Magnus”) is an innovative company that has developed and commercialized a SaaS-based offering to provide a FDA-cleared, personalized and targeted treatment of patients with Treatment Resistant Depression. Magnus is also developing similar solutions for other mental health conditions including but not limited to bipolar disorder, postpartum depression, and anxiety.
We are a venture-funded therapeutic medical devices company, led by industry veterans, with the mission of freeing individuals from the symptoms of depression and other neuropsychiatric diseases using personalized and accelerated neuromodulation technology. Our efforts are grounded in science, informed by clinical data, and inspired by the strength of those who live with psychiatric disease. We offer the ability to make the world a better place, in collaboration with like-minded colleagues who value communication, integrity, and cooperation. We are looking for individuals who are personally and boldly committed to improving treatment for mental health.
Position Summary:
As a Senior Clinical Research Associate (Senior CRA) at Magnus Medical, a medical device company focused on advancing treatments in mental health, you will be a critical member of the Clinical Affairs team. You will be responsible for overseeing the execution of clinical trials from site selection through close-out, ensuring adherence to study protocols, regulatory guidelines, and Good Clinical Practice (GCP). You will also provide operational leadership at the site level and contribute to study strategy, bringing a strong understanding of psychiatric and neurological study populations. You may also serve as a mentor to junior staff.
Key Responsibilities:
- Independently manage clinical monitoring activities for assigned clinical trial sites including site selection/qualification, initiation, routine monitoring, and close-out visits.
- Serve as a key liaison between Magnus and clinical trial sites, building strong site relationships and ensuring high engagement in trials involving sensitive patient populations.
- Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with investigators, key opinion leaders etc.
- Ensure the accuracy and integrity of data by reviewing source documents and case report forms (CRFs), with attention to detail.
- Monitor protocol compliance, subject safety, informed consent processes, and the proper administration of psychiatric scales.
- Identify and resolve site-level issues and escalate when appropriate.
- Remote and on-site training and support for site staff on protocol requirements, safety reporting, and accurate data collection.
- Develop study documents, including protocols, CRFs, monitoring plans, and informed consent forms.
- Collaborate closely with internal cross-functional teams including Regulatory Affairs, Data Management to ensure data quality and timeliness.
- Mentor and support junior CRAs, promoting consistency in trial conduct and monitoring approaches.
- Contribute to audit readiness and support regulatory inspections and site audits as needed.
- Contribute to process improvements across all aspects of clinical study operations.
Qualifications:
- Bachelor’s or advanced degree in Life Sciences, Nursing, Psychology, or a related field.
- Minimum 12 years of experience in clinical monitoring, with at least 10 years in medical device industry and/or with mental health/CNS therapeutic areas.
- Strong understanding of ICH-GCP, FDA regulations, and ethical considerations unique to psychiatric research.
- Proven ability to independently manage multiple sites and complex protocols.
- Experience with psychiatric rating scales and working with vulnerable populations is highly desirable.
- Strong interpersonal skills and ability to communicate effectively with investigators and site staff.
- Proficient in EDC systems, CTMS, and Microsoft Office.
- Willingness to travel up to 75%, depending on study needs.
Preferred Skills:
- Prior experience working directly for a sponsor organization in mental health.
- Familiarity with decentralized or hybrid clinical trial models.
- Experience with treatment-resistant mental health trials.
- ACRP or SOCRA certification is a plus.
Salary Range: $140,000 - $165,000 Annually
The annual base salary range for this position based in the United States is noted. This range is an estimate, and actual salary may vary based on Magnus' compensation practices, job-related skills, depth of experience, relevant certifications and training, and geographic location. Magnus utilizes the full width of the range. Our compensation package also includes an annual bonus based on company goals and an equity grant.
Company Statement
We are deeply committed to integrity, kindness, and communication, and these principles govern how we will build our teams and operate the company. Magnus is an equal opportunity employer. We value diversity and are committed to creating a positive, inclusive environment for all employees.