Senior Clinical Research Associate

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.