Signant Health is a global evidence generation company helping customers digitally enable their clinical trial programs. The Central Quality Reviewer (CQR) is responsible for data oversight, clinical analysis, and quality assurance for Signant Health Rater Training, Endpoint Reliability, and Quality Assurance programs.
Requirements
- 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.
- 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.
Benefits
- Signant Health is an equal opportunity workplace and is an affirmative action employer.
- Signant Health celebrates, supports, and nurtures diversity for the benefit of their team members, clients, and community.
