Careers in Quality

The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist provides quality improvement support through the analysis and application of regulations, policies and procedures related to human subjects research. This includes conducting routine and for-cause audits of the Human Research Protections Program (HRPP) (biomedical, social & behavioral) and research oversight programs and assists with the development and implementation of corrective and preventive action plans.

Regulatory Knowledge and Scientific Design

Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures.

Provides current and accurate compliance information and resources to the research community.

Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.

Thorough understanding of study design and the required elements of a research protocol in order to assess operational and compliance gaps or issues.

Quality Assurance Operations

Performs routine monitoring and for-cause auditing.

Conducts root-cause analysis to evaluate compliance, gathers relevant information, assesses impact, and determines steps to mitigate risk.

Documents detailed compliance findings and recommendations for assessment of the risks identified and the conclusions drawn.

Develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collaborative and educational manner.

Ensures responses and CAPA plans are implemented in a timely manner.

Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform routine and for-cause assessments of the HRPP. 

Assists in the management of external audits by regulatory agencies or business partners. Provides information and services to maintain FDA inspection readiness.

Demonstrates the ability to perform multiple tasks with a high level of accuracy and attention to detail.

Assists with site or study-specific self-assessments.

Research Operations

Describes the roles and responsibilities of research teams as defined by Good Clinical Practices (i.e. ICH-GCP, FDA, etc.).

Evaluates regulatory documents and participant source documents.

Reviews records relating to the appropriate control, storage, and dispensing of investigational products.

Identifies the types of adverse events (AEs) that occur during clinical trials and knows the reporting requirements to institutional review boards, sponsors, and regulatory authorities.

Identifies and explains the specific procedural, documentation, and oversight requirements of PIs, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

Data and Quality Improvement

Tracks metrics by collecting data on audit findings, preparing comprehensive reports, and analyzing trends.

Assists leadership with quality improvement projects and compliance training initiatives.

Presents data, trends, and risk assessments related to quality assurance activities.

Consistently prioritizes tasks to meet deadlines and produce requested quality assurance deliverables.

Leadership and Professionalism

Adheres to professional guidelines and codes of ethics that apply to the conduct of research.

Exhibits and prioritizes customer service across the HRPP.

Demonstrates and promotes the responsible conduct of research with an understanding of how compliance impacts participant rights and safety.

Demonstrates the ability to lead and collaborate across multi-disciplinary and interprofessional research teams.

Actively participates on relevant committees and work groups.

Contributes as a mentor or peer leader within the Institution.

Communication and Teamwork

Communicates effectively with study teams, research support services, investigators and research administration to accomplish shared objectives.

Manages communication with multiple stakeholders.

Provide direct feedback to investigators and research study teams guiding through compliance issues.

Other job functions as assigned.

Knowledge, Skills, and Abilities: 

Bachelors degree in a related field with 6 years relevant experience or Masters degree with 4 years of relevant work experience required.

Experience with coordinating/managing Phase I though Phase III clinical trials preferred.

Strong organizational and communication skills required; 2 years of training or leadership experience preferred.

Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research (e.g. ICH-GCP, OHRP, FDA regulations).

Professional certification in relevant area required (i.e., Certified IRB Professional (PRIM&R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.)

Technical aptitude in relevant quality improvement software (Excel, Word, Outlook, Access, PowerPoint; electronic medical records and data capture systems)