Clinical Rater

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/nephrology, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline.

(20 hours a week)

Duties and Responsibilities:

Clinical Rating & Assessment

• Administer and score validated rating scales in accordance with sponsor protocols, training guidelines, and rater certification requirements.
• Conduct structured and semi-structured diagnostic and symptom-based interviews with study participants.
• Perform baseline, post-baseline, and follow-up assessments as required by study protocols and visit schedules.
• Apply clinical judgment to ensure accurate, standardized, and unbiased ratings across all assessments.
• Maintain inter-rater reliability through participation in calibration exercises, reliability checks, and ongoing rater training as required by sponsors.
• Document all assessment results accurately and contemporaneously in source documents and EDC systems within required timelines.
• Adhere strictly to blinding procedures in blinded study designs to protect data integrity.

Participant Management

• Build and maintain positive, professional rapport with study participants to support engagement, retention, and reliable assessment completion.
• Educate participants on the purpose and procedures of rating assessments in a clear, supportive manner.
• Identify and promptly report any participant safety concerns, changes in clinical status, adverse events, or suicidality risk to the Investigator and clinical team.
• Maintain participant confidentiality in accordance with HIPAA and company policies.

Study Operations & Collaboration

• Collaborate with Clinical Research Coordinators, Investigators, and sponsor representatives to coordinate assessment scheduling within study visit windows.
• Participate in study start-up activities including protocol review, rater training, and certification exercises prior to site activation.
• Attend and actively participate in sponsor Investigator Meetings, rater training sessions, and calibration calls as required.
• Communicate assessment-related questions, protocol clarifications, and site issues to the Principal Investigator and site leadership in a timely manner.
• Support sponsor monitoring visits and audits by ensuring rating documentation is accurate, complete, and audit-ready.
• Perform phlebotomy or other study procedures only if qualified, trained, and delegated by the Principal Investigator (not required for this position).

Regulatory Compliance & Documentation

• Ensure all assessments and documentation comply with GCP, FDA regulations, ICH guidelines, HIPAA requirements, sponsor protocols, and site SOPs.
• Maintain rater qualification documentation, training records, and certification logs in the site regulatory binder and delegation of authority log.
• Complete sponsor-required rater qualification and reliability assessments prior to conducting study ratings.
• Immediately report any protocol deviations related to assessment conduct to the site coordinator and Principal Investigator.
• 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:

• Master's degree or higher in psychology, counseling, neuropsychology, social work, or a closely related clinical or behavioral health field required.
• Doctoral degree (Ph.D., Psy.D., or M.D.) preferred.
• Minimum of two (2) years of experience administering psychometric, psychiatric, cognitive, or behavioral rating scales in clinical research, clinical practice, or related settings.
• Minimum of two (2) years of clinical research experience in industry-sponsored interventional clinical trials required.
• Prior CNS/psychiatry clinical trial experience required.
• Experience supporting Phase I, II, III, and IV clinical trials.
• Familiarity with Good Clinical Practice (GCP), clinical trial procedures, and regulatory requirements.
• Experience conducting structured and semi-structured clinical interviews and assessments.
• Ability to obtain and maintain sponsor-specific rater certifications as required.
• Strong written, verbal, organizational, and documentation skills.
• Must be able to work on site at the Houston, TX location; occasional travel to the Dallas site may be required.
• Experience administering CNS rating scales and assessments, including but not limited to:
  • SCID-5-CT
  • C-SSRS
  • CGI
  • MADRS
  • HAM-A / HAM-D
  • ESS
  • MINI
  • LSAS
  • MGH-ATRQ
  • ISI
  • HDRS-17
  • PANSS
  • YMRS
  • ADAS-Cog
  • CDR
  • MMSE
  • BARS
  • AIMS
  • NPI-C / NPI
  • CMAI / CMAI-IPA
  • CGI-S
• Experience with sponsor certification processes, calibration exercises, and centralized rating programs.
• Certificates, licenses and registrations required: 
  • Texas licensure (e.g., LPC, LCSW, Licensed Psychologist) preferred; may be required by sponsors for certain scales.
  • Rater Qualification Certificate or willingness to obtain sponsor-specific certifications.
  • ACRP or SOCRA certification (preferred).
• Computer skills required:
  • Internet Software; 
  • Spreadsheet Software (Excel); 
  • Word Processing Software (Word); 
  • Electronic Mail Software (Outlook); 
  • Presentation software (PowerPoint); 
  • Experience with Electronic Data Capture (EDC) systems
  • Experience with RealTime CTMS
  • Experience with eRegulatory systems
  • Experience with Electronic Medical Records (EMR/EHR)
  • Proficiency with Microsoft Office Suite and Adobe Acrobat
• Other skills required:
  • Fluency in Spanish is preferred.
  • Strong attention to detail and accuracy
  • Strong clinical interviewing and assessment skills.
  • Strong organizational and time management skills
  • Effective communication and interpersonal skills
  • Ability to maintain confidentiality and professionalism
  • Ability to exercise sound judgment and decision-making
  • Ability to follow protocols, SOPs, and regulatory requirements

Physical Requirements and/or environmental factors:

• Continually required to stand.
• Continually required to walk.
• Continually required to sit.
• Continually required to utilize hand and finger dexterity.
• Occasionally required to climb, balance, bend, stoop, kneel or crawl.
• Continually required to talk or hear.
• Continually 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
• 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.