Clinical Rater

American Clinical Research Services Opco LLC•Houston, TX

4d•$65 - $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/nephrology, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline.

Requirements

Master's degree or higher in psychology, counseling, neuropsychology, social work, or a closely related clinical or behavioral health field required.
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.
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.
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
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

Nice To Haves

Doctoral degree (Ph.D., Psy.D., or M.D.) preferred.
ACRP or SOCRA certification (preferred).
Fluency in Spanish is preferred.

Responsibilities

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.
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.
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.
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.