Sub-Investigator; Part-Time

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Part Time Dallas, TX, US

3 days ago Requisition

Salary Range: $60.00 To $100.00 Hourly

At Empathx, we drive equitable access to complex trials at any phase by providing industry-leading patient access, clinical trial management, and analysis across cardiology, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline.

This is an on-site, part-time position at our Dallas, TX location. The schedule is 3-4 days per week, for a total of 20-24 hours per week. Specific days and hours will be set with the site based on study visit needs.

The Sub-Investigator provides medical oversight for clinical trials under the direction of the Principal Investigator, with a focus on psychiatry/CNS studies across Phases I-IV. This role assesses participant eligibility and safety, performs protocol-required clinical assessments, and ensures studies are conducted in compliance with the protocol, ICH-GCP, and FDA regulations.

• Conduct clinical trials under the direction and delegation of the Principal Investigator in accordance with the protocol, ICH-GCP, FDA regulations (21 CFR Parts 50, 54, 56, and 312), IRB requirements, and company SOPs
• Provide medical oversight across a portfolio of five or more concurrent studies, Phases I-IV, with a focus on psychiatry/CNS indications
• Assess participant eligibility by reviewing medical and psychiatric history, concomitant medications, and inclusion/exclusion criteria prior to enrollment and randomization
• Conduct and document the informed consent process, ensuring participants understand study procedures, risks, and their rights
• Evaluate, document, and report adverse events (AEs) and serious adverse events (SAEs), including severity and relationship to investigational product, within protocol-required timelines
• Review psychiatric safety assessments, including suicidality screening, and elevate safety concerns to the Principal Investigator per protocol and company SOPs
• Ensure participant safety, rights, and well-being are protected throughout study participation

• Perform physical examinations and other protocol-required clinical assessments at screening and study visits
• Review vital signs, ECGs, and laboratory results for clinical significance and document investigator assessment
• Perform blood draws and other study procedures as needed, within scope of licensure and delegation
• Make protocol-driven decisions on investigational product dosing, holds, and discontinuation within scope of licensure and in consultation with the Principal Investigator

• Document all assessments and investigator decisions in source documents in a timely, accurate manner consistent with ALCOA+ principles
• Review and sign off on source documents, case report forms (CRFs), and EDC entries as delegated
• Respond to data queries and monitor findings in a timely manner

• Perform only those study tasks delegated by the Principal Investigator and documented on the Delegation of Authority log
• Maintain current regulatory documents, including CV, license, GCP training, financial disclosure, and Form FDA 1572 listing
• Participate in site initiation visits, investigator meetings, monitoring visits, and sponsor/CRO communications as required
• Collaborate with Clinical Research Coordinators, Clinical Raters, and research staff to ensure protocol compliance and quality participant care
• Support audit and inspection readiness, including participation in sponsor…