Empathx

Overview: 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.

Position Summary: The Clinical Rater is a licensed mental health professional responsible for conducting standardized psychiatric and neurological assessments in support of clinical research studies. This position requires specialized expertise in the administration and scoring of validated rating scales used in CNS and psychiatry trials, including mood, psychosis, anxiety, cognition, and functional outcome measures. The Clinical Rater plays a critical role in ensuring the integrity, consistency, and reliability of study data by conducting assessments in strict accordance with sponsor protocols, training requirements, Good Clinical Practice (GCP) guidelines, and site SOPs. This position is based in Texas and requires on-site availability to support study visit schedules.

Duties and Responsibilities:

• Clinical Rating & Assessment
• Administer and score validated psychiatric and neurological 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.
• Rating Scale Experience
• Candidates must provide a comprehensive list of rating scales they have administered as part of the application process. Experience with the following scales is highly valued:
• Depression: Hamilton Depression Rating Scale (HDRS/HAM-D), Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire (PHQ-9), Beck Depression Inventory (BDI)
• Anxiety: Hamilton Anxiety Rating Scale (HAM-A), Generalized Anxiety Disorder Scale (GAD-7), Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
• Psychosis & Schizophrenia: Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), Scale for the Assessment of Negative Symptoms (SANS)
• Global & Functional: Clinical Global Impression (CGI-S, CGI-I), Global Assessment of Functioning (GAF), Columbia Suicide Severity Rating Scale (C-SSRS)
• Cognition: Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Cogstate, MATRICS Consensus Cognitive Battery (MCCB)
• Mania & Bipolar: Young Mania Rating Scale (YMRS)
• ADHD & Neurodevelopmental: Conners’ Rating Scales, ADHD Rating Scale (ADHD-RS)
• Other CNS/Neurology scales as required by assigned protocols
• 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.
• 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 clinical psychology, counseling psychology, neuropsychology, psychiatry, or a closely related mental health field required.
• Active licensure or license-eligible status in the state of Texas required (e.g., LPC, LPC-A, LCSW, Licensed Psychologist).
• Doctoral degree (Ph.D., Psy.D., or M.D.) preferred.
• Must be a Clinical Psychologist with appropriate licensure, licensure eligibility, or credentials as required by applicable regulations and study requirements.
• Minimum of two (2) years of experience administering psychometric, psychiatric, cognitive, or behavioral rating scales in clinical research, clinical practice, or related settings.
• Previous clinical research experience required, preferably in industry-sponsored clinical trials.
• Previous interventional clinical trial experience required.
• 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 located in Texas.
• Experience administering psychiatric, mood disorder, cognitive, and neurodegenerative disease assessments, including but not limited to: 
  • SCID-5-CT 
  • MINI 
  • LSAS 
  • HAM-A / HAM-D 
  • MADRS 
  • MGH-ATRQ 
  • ISI 
  • CGI 
  • HDRS-17 
  • PANSS 
  • YMRS 
  • ADAS-Cog 
  • CDR 
  • MMSE 
  • C-SSRS 
  • 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:
  • Licensed Clinical Psychologist in the State of Texas, or license eligible if permitted by study requirements.
  • 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 Clinical Trial Management Systems (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:

• Frequently required to stand.
• Frequently 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.
• Occasionally 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: 
  • o 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.