Sub-Investigator (Part-Time) in Dallas, Texas at American Clinical Research Services Opco LLC

About Us

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.

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.

Duties and Responsibilities:

Study Oversight & Participant Safety

• 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

Clinical Assessments & Procedures

• 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

Documentation & Data Integrity

• 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

Regulatory & Sponsor Communication

• 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

Qualifications:

• 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.

Certificates, licenses and registrations required:

• ACRP or SOCRA certification (preferred)

Systems & Technology skills 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

Other skills required:

• Fluency in Spanish is preferred.
• 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

Physical Requirements and/or environmental factors:

• Frequently required to stand.
• Frequently required to walk.
• Frequently required to sit.
• Continually required to utilize hand and finger dexterity.
• Frequently required to climb, balance, bend, stoop, kneel or crawl.
• Continually required to talk or hear.
• Occasionally works around fumes, airborne particles, or toxic chemicals.
• Frequently exposed to bloodborne and airborne pathogens or infectious materials.
• While performing the duties of this job, the noise level in the work environment is usually moderate
• The employee must
  • Occasionally lift and/or move up to 20 pounds
• Specific vision abilities required by this job include:
  • Close vision
  • Distance vision
  • Color vision
  • Peripheral vision
  • Depth perception
  • Ability to adjust focus
• Specialized equipment, machines, or vehicles used:
  • Stethoscope, blood pressure monitor, ECG machine, phlebotomy supplies, and other standard clinical equipment
• This position operates in a clinical research and office setting. The role involves interaction with study participants, healthcare professionals, and research staff. Work may include use of electronic systems and medical equipment, as well as occasional travel to clinical sites or meetings.

Equal Opportunity: Empathx is committed to fostering a diverse, inclusive, and equitable workplace where all employees and applicants are treated with respect and dignity. We are proud to be an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, marital status, national origin, ancestry, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law.