Sub-Investigator (Part-Time)

American Clinical Research Services Opco LLC•Dallas, TX

6d•$60 - $100•Onsite

About The Position

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. Position Summary: 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.

Requirements

Current and unrestricted licensure as a physician (MD/DO), Nurse Practitioner (NP), or Physician Assistant-Certified (PA-C) in the State of Texas.
Master's Degree (MA) or equivalent, or four to ten years of related experience and/or training, or equivalent combination of education and experience.
Previous experience as a Sub Investigator or Clinical Research Coordinator in clinical trials.
Familiarity with electronic data capture (EDC) systems and clinical trial management software.
Prior psychiatry/CNS therapeutic area experience required.
Experience with Phase I–IV clinical trials required.
Spreadsheet Software (Excel)
Word Processing Software (Word)
Electronic Mail Software (Outlook)
Presentation software (PowerPoint)
Experience with EDC systems (e.g., Medidata Rave, REDCap)
Experience with CTMS and/or eRegulatory/eTMF platforms (e.g., Veeva)
Experience with EMR/EHR systems
Strong attention to detail and accuracy
Ability to manage multiple tasks and priorities
Strong organizational and time management skills
Ability to work independently and as part of a team
Effective communication and interpersonal skills
Ability to maintain confidentiality and professionalism
Strong problem-solving and critical thinking skills
Ability to adapt to changing priorities
Ability to exercise sound judgment and decision-making
Customer service mindset with focus on patient experience
Ability to follow protocols, SOPs, and regulatory requirements
Ability to handle high-pressure or fast-paced environments

Nice To Haves

ACRP or SOCRA certification (preferred)
Fluency in Spanish is preferred.

Responsibilities

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 escalate 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 audits, regulatory inspections, and internal quality reviews
Complete all required SOP training and company-required trainings as assigned and when updated
Maintain all required licenses and certifications and ensure they remain current and in good standing
Travel to company meetings, site locations, or study-related activities as required
Perform other duties as assigned