Central Quality Reviewer - Operations

Signant Health; Ciudad de México; A distancia; MXN 735,000 - 1,103,000; Jornada completa

Descripción de la vacante

A global evidence generation company is seeking a Central Quality Reviewer to provide data oversight and conduct quality assurance in clinical trials. Candidates should hold a Master's degree and have clinical experience, particularly with psychiatric scales. Join a dynamic team that values inclusivity and innovative solutions in the healthcare sector.

Formación

• One year of clinical experience involving psychiatric and/or cognitive scales.
• Experience with data interpretation and statistics.
• Fluency in English for daily business communications.

Responsabilidades

• Conduct activities in accordance with Good Clinical Practice guidelines.
• Evaluate data and provide feedback to raters.
• Monitor quality review of CQR activities.

Conocimientos

Attention to detail

Analytical skills

Problem-solving skills

Communication skills

Time management

Organizational skills

Knowledge of psychiatric scales

Educación

Master’s Degree, M.D., Ph.D., Psy.D, Pharm.D

Bachelor’s degree or RN

Herramientas

Clinical Dementia Rating (CDR)

Mini Mental State Examination (MMSE)

Structured Clinical Interview for DSM Disorders (SCID)

Neuropsychiatric Inventory – Clinician (NPI-C)

Descripción del empleo

Overview

Are you ready for the Most Impactful Work of Your Life?

Signant Health is a global evidence generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations and reimagining the path to proof. Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry.

Where do you fit in?

The Central Quality Reviewer (CQR) is responsible for the services/tasks to deliver defined requirements and meet 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 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 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.

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, as appropriate, 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 by CQRs as indicators of their performance.
• Works with clinical team to ensure study start up is completed for the program, including the development of materials for CQR onboarding, training, quality assurance, etc.
• Proactively identifies and escalates potential issues appropriately.
• Supports the development of site relationships to ensure that the site staff are trained and calibrated to the study-specific and universal standards.
• Communicates with investigational site staff providing feedback and instruction, as needed.

Decision Making and Influence

• Facilitates and maintains team and corporate culture of collegiality, respect, and professional support.
• Capable of weighing risks and making decisions that align with Signant Health values and strategy.
• Manage customer escalations effectively, with follow up and closure.

You’ll need to bring

• Master’s Degree, M.D., Ph.D., Psy.D, Pharm.D., in healthcare-related field, with one year of clinical experience, which includes administration of psychiatric and/or cognitive scales OR Bachelor’s degree or RN with 2 years of clinical experience, which includes administration of psychiatric and/or cognitive scales.
• Must be comfortable providing investigator and peer remediation.
• Demonstrates a significant attention to detail.
• Must be comfortable working in a virtual, remote environment with individuals from diverse countries, languages, and cultures.
• Exhibited strong analytical, organizational, and creative problem-solving skills.
• Deep knowledge of psychiatric and/or cognitive scales.
• Basic knowledge of statistics. Able to work with and interpret data and numbers.
• Excellent problem and/or dispute resolution skills.
• Must have excellent written, time management, communications, decision making, human relations and organizational skills, including fluency in English (will be required to write, speak, and understand English to conduct day-to-day business).
• Experience with at least one of the following Scales is mandatory:
  • Clinical Dementia Rating (CDR)
  • Mini Mental State Examination (MMSE)
  • Structured Clinical Interview for DSM Disorders (SCID)
  • Neuropsychiatric Inventory – Clinician (NPI-C)

Language: Resumes must be submitted in English.

Ready to join the adventure?Apply now and be a part of Signant Health’s exciting journey!

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At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.