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Senior Clinical Research Associate
Magnus Medical. Independently manage clinical monitoring activities for assigned clinical trial sites, including site selection/qualification, initiation, routine monitoring, and close-out visits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical monitoring, including site management, protocol compliance, and data integrity within psychiatric research. Proficient in collaborating with diverse stakeholders and mentoring junior staff while ensuring adherence to regulatory standards.
Highest-signal resume keywords
Clinical Monitoring ExperienceICH-GCP UnderstandingEDC Systems ProficiencyInterpersonal Communication SkillsACRP or SOCRA Certification
ATS Keywords
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Hard Skills
Clinical Trial ManagementData Accuracy ReviewProtocol Compliance MonitoringPsychiatric Rating Scales ExperienceStudy Document Development
Soft Skills
Relationship BuildingProblem SolvingMentoring
Tools & Technologies
EDC SystemsCTMSMicrosoft Office
Certifications & Qualifications
ACRP CertificationSOCRA Certification
Industry Keywords
Mental HealthCNS Therapeutic AreasRegulatory ComplianceClinical Study OperationsDecentralized Clinical Trials
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Annual bonus based on company goals
- Equity grant
- Inclusive and positive work environment
- Equal opportunity employment