Central Quality Reviewer

Careers Signant Health
•Remote

About The Position

The Central Quality Reviewer (CQR) is responsible for delivering defined requirements and meeting company strategic objectives. The CQR provides data oversight for Signant Health Rater Training, Endpoint Reliability, and Quality Assurance programs. The CQR will provide clinical analysis for psychiatric and cognitive scales used as study endpoints to detect the degree of administration and scoring calibration to standard training principles and best practice. The CQR will provide email and telephone remediation to investigators and study staff as needed to recalibrate to study standards. The CQR may interview study participants or provide independent scoring of endpoint scales on submitted audio or video files. This role requires deep expertise in psychiatric assessments, including Major Depressive Disorder (MDD) and cognitive/dementia rating scales, with the ability to assess both protocol adherence and rater calibration across diverse populations and clinical indications.

Requirements

  • Master's Degree, M.D., Ph.D., Psy.D., or Pharm.D. in healthcare-related field with one year of clinical experience that includes administration of psychiatric and/or cognitive scales, OR Bachelor's degree or RN with 2+ years of clinical experience including administration of psychiatric and/or cognitive scales.
  • Clinical experience must include demonstrated expertise with psychiatric assessments (particularly depression and anxiety rating scales) and cognitive/dementia assessments.
  • Fluency in Spanish (written and verbal) required to provide investigator remediation and training across Spanish-speaking study sites and populations.
  • Deep knowledge of psychiatric and/or cognitive scales, including but not limited to MDD assessments and dementia/cognitive decline rating instruments.
  • Must be comfortable providing investigator and peer remediation with strong attention to detail.
  • Demonstrated strong analytical, organizational, and creative problem-solving skills.
  • Basic knowledge of statistics; able to work with and interpret data and numbers.
  • Excellent problem and/or dispute resolution skills.
  • Excellent written, time management, communications, decision-making, human relations, and organizational skills.
  • Must be comfortable working in a virtual, remote environment with individuals from diverse countries, languages, and cultures.

Responsibilities

  • Conducts all activities in full accordance with Good Clinical Practice guidelines.
  • Contributes to training, calibration exercises, and quality control procedures for respective projects assigned.
  • Evaluates data submitted in accordance with Rater Training Program (e.g., Interview Skills) and Endpoint Reliability programs and contacts raters to gather additional information and provide feedback.
  • Ensures consistency of review and remediation process and resolves ambiguities in collaboration with study team and other stakeholders.
  • May interview subjects and/or informants according to scale and protocol specifications; may provide independent scoring data based on review of audio and video files.
  • Monitors and conducts quality review of internal and external CQRs' activities by reviewing both the data and documentation entered as indicators of their performance.
  • Works with clinical team to ensure study start-up is completed for the program, including development of materials for CQR onboarding, training, and quality assurance.
  • Proactively identifies and escalates potential issues appropriately.
  • Supports development of site relationships to ensure that site staff are trained and calibrated to study-specific and universal standards.
  • Communicates with investigational site staff providing feedback and instruction as needed, in English and Spanish.

Benefits

  • Collaborative, global environment
  • Opportunities to learn, take ownership, and drive meaningful innovation
  • Purpose-driven work
  • Smart colleagues
  • Opportunity to help shape the future of clinical research and digital health
  • Accepting difference is celebrated, supported, and nurtured
  • Equal opportunity workplace
  • Affirmative action employer
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