Psychiatric NP / Psychiatric APRN / NP Sub Investigator

About the role

The Sub-Investigator serves as a secondary clinician responsible for clinical and medical oversight at the research site, acting on behalf of the Principal Investigator as needed. This role supports the execution of clinical trials in compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements while ensuring subject safety and data integrity.

Key Responsibilities

• Conduct subject medical visits and oversee clinical aspects of active studies
• Support patient recruitment and enrollment efforts
• Ensure protocol adherence, informed consent compliance, and subject safety
• Evaluate and report adverse events per protocol and regulatory guidelines
• Collaborate with the Principal Investigator, study monitors, IRB, and site staff
• Participate in investigator meetings, monitoring visits, and audits
• Ensure accuracy, completeness, and timeliness of clinical trial data and documentation
• Oversee proper use and storage of investigational products
• Absorb with study feasibility review and selection
• Communicate effectively with sponsors, research teams, and subjects

Regulatory & Compliance Duties

• Maintain active medical licensure and current CV
• Sign required regulatory documents (FDA 1572, protocols, sponsor agreements)
• Ensure IRB approvals are obtained and maintained
• Uphold subject rights, welfare, and confidentiality
• Ensure compliance with GCP, ICH guidelines, and SOPs

Qualifications

• APRN with active medical license required
• Experience as a Sub-Investigator in industry-sponsored clinical trials preferred
• Knowledge of FDA regulations, IRB requirements, and GCP standards
• Strong attention to detail and commitment to subject safety
• Ability to work collaboratively in a clinical research environment
• Preference for psychiatric nursing experience